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Showing 1-20 of 128 trials
NCT03050268
NOTE: This is a research study and is not meant to be a substitute for clinical genetic testing. Families may never receive results from the study or may receive results many years from the time they enroll. If you are interested in clinical testing please consider seeing a local genetic counselor or other genetics professional. If you have already had clinical genetic testing and meet eligibility criteria for this study as shown in the Eligibility Section, you may enroll regardless of the results of your clinical genetic testing. While it is well recognized that hereditary factors contribute to the development of a subset of human cancers, the cause for many cancers remains unknown. The application of next generation sequencing (NGS) technologies has expanded knowledge in the field of hereditary cancer predisposition. Currently, more than 100 cancer predisposing genes have been identified, and it is now estimated that approximately 10% of all cancer patients have an underlying genetic predisposition. The purpose of this protocol is to identify novel cancer predisposing genes and/or genetic variants. For this study, the investigators will establish a Data Registry linked to a Repository of biological samples. Health information, blood samples and occasionally leftover tumor samples will be collected from individuals with familial cancer. The investigators will use NGS approaches to find changes in genes that may be important in the development of familial cancer. The information gained from this study may provide new and better ways to diagnose and care for people with hereditary cancer. PRIMARY OBJECTIVE: * Establish a registry of families with clustering of cancer in which clinical data are linked to a repository of cryopreserved blood cells, germline DNA, and tumor tissues from the proband and other family members. SECONDARY OBJECTIVE: * Identify novel cancer predisposing genes and/or genetic variants in families with clustering of cancer for which the underlying genetic basis is unknown.
NCT07286318
A Randomized Controlled Trial of Topical 5% Niacinamide for Skin Cancer Prevention in Organ Transplant Recipients This study is designed to evaluate whether a topical 5% niacinamide cream can help prevent skin cancer in organ transplant recipients. Individuals who have received an organ transplant have a much higher risk of developing precancerous skin growths and skin cancers because of long-term immune-suppressing medications. Although sunscreen is an important part of sun protection, additional preventive approaches are needed. Early research suggests that niacinamide may help protect the skin, and this trial will examine whether a topical formulation provides benefit in this high-risk group. The study will test whether daily use of topical 5% niacinamide reduces the number of actinic keratoses over 6 and 12 months and whether it decreases the development of new keratinocyte cancers when compared with sunscreen alone. The study will also evaluate how well the topical product is tolerated and whether it can be used consistently as part of a daily skin-care routine. A total of 20 adult organ transplant recipients with a history of multiple actinic keratoses and at least one prior non-melanoma skin cancer will enroll in this 12-month, randomized, controlled trial. Participants will be assigned to receive either daily topical 5% niacinamide plus sunscreen or sunscreen alone. Skin examinations will be performed at 6 and 12 months using standardized mapping methods. Information on treatment tolerability, adherence, and any side effects will be collected through structured surveys, and any lesions suspicious for cancer will be evaluated by a board-certified pathologist.
NCT06817590
The goal of this clinical trial is to learn if a combination therapy of deoxycytidine (dC) plus deoxythymidine (dT) is safe in patients with telomere biology disorders. The main questions it aims to answer are: * Is the therapy safe with tolerable side effects in patients with telomere biology disorders? * Are problems with the bone marrow or blood or lungs changed after 6 months of dC+dT treatment in patients with telomere biology disorders? Participants will: * Take study drug by mouth three times daily for 24 weeks * Make approximately 2 visits to Boston Children's Hospital during the 24 weeks: once at the beginning of treatment and once at the end of treatment. * Go to a lab for a blood draw an additional 6 times during treatment. * Have 9 phone calls with a research nurse, including one 4 weeks after treatment ends. * Keep a diary to track doses of study drug that were taken or missed.
NCT07441538
What is this study about? You are being invited to participate in a clinical research study because you are scheduled to undergo a facial skin surgery for your health condition. Your surgeon will perform your operation independently, and your standard surgical procedure and follow-up visits will not be changed in any way by this study. The purpose of this research is to understand which postoperative care method is more beneficial for facial wound healing and for reducing scar formation. We aim to compare two common approaches for caring for the wound after surgery. Your participation will help doctors choose better care plans for future patients. What will happen in this study? If you agree to participate, you will be randomly assigned (like drawing lots) to one of two groups: Group A (Early Exposure Group): About 6 hours after your surgery, the doctor will remove the sterile gauze covering your wound. After this, you will need to keep the wound area clean and dry, and you will not use a gauze dressing to cover it. Group B (Continuous Coverage Group): After surgery, your wound will continue to be covered with sterile gauze. The doctor or nurse will change the dressing for you regularly until the sutures are removed around 7 days after surgery, or until it is decided to stop based on how the wound is healing. What will I need to do differently? Apart from the assigned wound care method described above, participating in this study involves only the following additions to your regular care: Before Surgery: You will be asked to fill out a simple questionnaire about your skin and undergo a quick, non-invasive skin measurement. During Follow-up Visits: You will be asked to fill out questionnaires and allow the study doctor to take photographs of your surgical area. These photos will be used only for analysis and record-keeping in this study. Your total time commitment for these extra activities is minimal. Participation is entirely voluntary, and your decision will not affect the quality of your medical care. Key Information: Your surgeon decides your operation. This study only involves postoperative wound care. Random Assignment: You cannot choose your group; it is decided randomly by a computer. Privacy: Your personal information and study data (including photos) will be kept strictly confidential and used only for this research. Potential Benefit: You may not benefit directly, but your participation will contribute to medical knowledge. Potential Risks: The risks are considered minimal and are similar to those of standard wound care. The study doctor will monitor your healing closely. You will receive a detailed informed consent form with more information. Please discuss any questions you have with the research team before deciding.
NCT06731036
Allogeneic stem cell transplantation (alloSCT) is utilized for various underlying diseases. AlloSCT is limited by graft versus host disease (GVHD), graft rejection, viral infections, and post-transplant lymphoproliferative disorders. To mitigate graft versus host disease, graft manipulation has been taking place with CD34+ selection to decrease T-cells entering into the patient, thus lowering the risk of GVHD. Historically CD34+ manipulation has been performed under a humanitarian use device by utilizing the Miltenyi CliniMACs CD34 Reagent System. This was used for patients with AML in first remission. This approach has additionally been used for patients with sickle cell disease, immune deficiencies, and poor graft function with excellent efficiency. The purpose of this protocol is to create expanded access of CD34+ manipulation for various underlying diseases utilizing the Miltenyi CliniMACS Prodigy® device.
NCT03579875
This is a phase II trial of T cell receptor alpha/beta depletion (α/β TCD) peripheral blood stem cell (PBSC) transplantation in patients with inherited bone marrow failure (BMF) disorders to eliminate the need for routine graft-versus-host disease (GVHD) immune suppression leading to earlier immune recovery and potentially a reduction in the risk of severe infections after transplantation.
NCT06888362
This is a double-blind, randomised, placebo-controlled trial designed to evaluate safety, tolerability, and pharmacokinetics (PK) after topical administration of single ascending doses of GZ21T in healthy volunteers.
NCT07340697
This clinical trial will assess the safety and tolerability of topical application of RLS-1496 cream to lesions and adjacent skin on the left forearm of adults with actinic keratoses (AK) on the arms. The right forearm will remain untreated as a control. The therapeutic objective of topical treatment with RLS-1496 cream is to clear or decrease the number of AK in the treated area, per lesion counts performed by the Investigator. The main questions it aims to answer are: * Is it safe to apply topical RLS-1496 cream to treat AK once daily for 28 days? * Does topical RLS-1496 lower the number of AKs or eliminate AKs in a treated area when applied once daily for 28 days? Researchers will compare results on the left (treated with RLS-1496) and right (no treatment) forearm. Participants will apply RLS-1496 to an identified area on the left forearm once each day for 28 days and have intermittent clinic visits to examine the arms and have the AK lesions counted until 28 days after the last application of RLS-1496. Participants will also have small skin biopsies on the arms.
NCT01659606
Dyskeratosis congenita is a disease that affects numerous parts of the body, most typically causing failure of the blood system. Lung disease, liver disease and cancer are other frequent causes of illness and death. Bone marrow transplantation (BMT) can cure the blood system but can make the lung and liver disease and risk of cancer worse, because of DNA damaging agents such as alkylators and radiation that are typically used in the procedure. Based on the biology of DC, we hypothesize that it may be possible to avoid these DNA damaging agents in patients with DC, and still have a successful BMT. In this protocol we will test whether a regimen that avoids DNA alkylators and radiation can permit successful BMT without compromising survival in patients with DC.
NCT07318675
This is a phase Ib study to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of HW211026 ointment after single or multiple topical administrations in patients with actinic keratosis.
NCT06778434
The purpose of this study is to test the use of topical imipramine in combination with topical photodynamic therapy's (PDT) effect on the effectiveness and pain immunosuppression following treatment. PDT is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis or "AK") on their skin. These are both FDA-approved medications, but this study is evaluating their use in combination, which has not been evaluated in the past. The investigators have been doing studies using mice that suggest imipramine might reduce immune system suppression by PDT thus allowing it to work better. Subjects whose provider has decided that they may benefit from PDT to treat their skin due to many AK precancerous lesions will be recruited for this study. Please note that the PDT itself is not experimental, only the imipramine treatment to the skin. There is a separate informed consent for the PDT.
NCT07290959
Several treatments are available for actinic keratosis (AK), many of which are hampered by local inflammation, pain, long duration, and slow healing. Indoor daylight photodynamic therapy (idl-PDT) is an effective, well-tolerated, first-line treatment for both AK and field cancerization, but the feasibility of this treatment is limited by the long time required for the illumination (2 hours). Objective of this study was to evaluate the efficacy of idl-PDT with an illumination time of 1 hour versus 2 hours in the treatment of scalp AK. Adult patients (age \>50 years) with multiple AK located on the scalp (at least 5 Olsen grade I or II AK in two symmetrical areas) and diagnosed according to the typical clinical appearance were enrolled at two Dermatology Units in Italy. Exclusion criteria were the followings: previous treatment for AK within 6 months; status of congenital, infectious, or iatrogenic immunodepression; known cutaneous photosensitivity; known hypersensitivity to any ingredient of Metvix® 135 mg/g cream (Galderma SA, Lausanne, Switzerland). AK lesions on the scalp were mapped photographically with the support of a transparent sheet and graded according to Olsen grading scale. Two contralateral and symmetric areas of the scalp containing at least 5 AK were identified. Randomization of the two target areas for the two illumination durations (1 hour vs 2 hours) was performed with a 1:1 allocation ratio with a computer-generated list using permuted random blocks of six to ensure allocation concealment. At baseline, the following data were recorded: age, sex, phototype, Olsen grade and number of AK per side, any previous therapies on the treated area, any previous surgical excision of malignant skin neoplasms on the treated area, and comorbidities. The skin area to be treated was prepared with a sterile gauze pad soaked in saline solution to remove scales and crusts and then a 1 mm thick layer of cream containing 160mg/g of MAL (Metvix®) was applied. After 30 minutes of application, according to clinical practice and approved protocol, exposure to the white polychromatic LED lamp (Dermaris®, Surgiris, Croix, France, 400-700nm, fixed distance 30 cm, irradiance 72.6 W/m2 156 ) was performed, for a duration of 1 hour on one half and 2 hours on the other half, according to randomization. The emission spectrum of the light source was measured with a SR 9910 spectroradiometer (Macam Photometrics Ltd, Livingston, UK). The light doses were 26.1 J/cm2 for 1 hour illumination and 52.3 J/cm2 for 2 hours illumination, and the effective light doses for PpIX photoactivation were 0.69 Jeff/cm2 160 for 1 hour illumination and 1.39 Jeff/cm2 for 2 hours illumination. The effective light dose was calculated with the normalized PpIX absorption spectrum, the spectral irradiance of the lamps and treatment duration. Patients were evaluated 3 months and 6 months after the idl-PDT session to assess the efficacy of the two illumination times. A clinical photograph of the treated area was taken after 1 hour, 24 hours, and at each of the two follow-up visits. The primary endpoint of the study was the lesion response rate at 3 months. The analysis was performed on the total number of AK and after categorization of AK according to Olsen clinical grade. The secondary endpoints were lesion response rate at 6 months, tolerability and physicians' and patients' satisfaction. Tolerability was assessed as follows: subject's assessment of maximal pain perceived according to treated side immediately after the end of the treatment on a 0-10 numeric rating scale (NRS), from 0 (no pain) to 10 (extreme pain); local skin reactions (LSRs) assessed 1 hour and 24 hours after the treatment, including erythema, scaling, crusting, edema, blistering/pustulation and erosion/ulceration, each classified according to a 0-4 scale of severity (total LSR score range: 0-24). At the 3-months follow up visit, physicians rated their level of satisfaction on a 4-point scale with respect to treatment efficacy (very effective, effective, poorly effective, ineffective) and cosmetic outcome (excellent, good, poor or worse) for each treated area. In addition, patients were administered a questionnaire to globally assess convenience of the treatment (very convenient, convenient, poorly convenient, inconvenient) and overall level of satisfaction (very satisfied, satisfied, poorly satisfied, not satisfied at all) on a 4-point scale. The patient's willingness to undergo any further treatment with idl-PDT was recorded.
NCT04232085
Phase II prospective trial to assess the rates of donor engraftment using reduced intensity conditioning (RIC) hematopoietic stem cell transplant (HSCT) and post-transplant cyclophosphamide (PTCy) for patients with primary immune deficiencies (PID), immune dysregulatory syndromes (IDS), inherited bone marrow failure syndromes (IBMFS), short telomere syndromes, Fanconi anemia, and non-Fanconi DNA double-strand break (DNA-dsb) repair disorder.
NCT05699603
This phase IIA study evaluates the effects of calcipotriene plus 5- fluorouracil immunotherapy for skin cancer prevention in organ transplant recipients. Solid organ transplant recipients are at high risk of developing skin cancer. Actinic keratosis (AK), is a premalignant skin lesion that can progress to squamous cell skin cancer. In this study, solid organ transplant recipients with multiple AKs are treated with topical calcipotriene and 5-FU to evaluate how effective this therapy is against AKs and if this could lower their risk of skin cancer. Topical calcipotriene is a form of vitamin D and is used to treat psoriasis. Prior research reported immunomodulatory effects in the skin induced by topical calcipotriene. Topical 5- fluorouracil is a chemotherapy agent and is one of the therapy options for multiple AKs in specific clinical scenarios. Prior research indicates that topical calcipotriene used together with topical 5-FU was more effective in treating multiple AKs than 5-FU alone in individuals with healthy immune system. This study is investigating now if similar beneficial effects can be seen in immunosuppressed individuals who are solid organ transplant recipients.
NCT07137819
The goal of this clinical trial is to show superiority of Veregen® 10% ointment to Placebo measured by complete (100%) clearance of a pre-defined treatment area (TA) following a treatment period of 12 weeks and a 4-weeks post-treatment (PT) period (i.e., after 16 weeks at most in patients without complete clearance at the end of the treatment (EoT) period).
NCT04638517
TELO-SCOPE is a national, multi-centre, double-blind, placebo-controlled, randomised (2:1) trial which will test the hypothesis that, compared to placebo, the addition of danazol to standard of care in pulmonary fibrosis associated with short telomeres is safe and will result in reduced telomere attrition.
NCT06648447
The aim of this study is to observe the influence of tirbanibulin on proliferation patterns of actinic keratoses (efficacy on proliferation score according to Schmitz et al.). For this purpose, tirbanibulin is applied in-label, proliferation is measured by LC-OCT at different time points and dermatohistopathology is performed (optionally) at the end. Local skin reactions to the product will also be recorded (tolerability).
NCT00472459
Participants on immunosuppressive therapy, e.g., organ recipients, had higher occurrence of AK (Actinic Keratosis) than the untreated population. Keratotic lesions (i.e., AK lesions and warts) in this population were highly associated with development of SCC (Squamous Cell Carcinoma) also with 10 times higher mortality rate because of SCC than expected. The risk of developing skin cancer, predominantly SCC and BCC (Basal Cell Carcinoma), increased with graft survival time and the length of immunosuppressive treatment period. The higher risk of developing skin malignancy and more aggressive skin malignancies in this population, indicated the need for early removal of these pre-malignant lesions. In this study, two contralateral areas (5x10 cm\^2) with skin lesions within the participant were compared. One area was received Metvix PDT at defined intervals and the other was received lesion specific treatment at the discretion of the investigator. The primary endpoint was the accumulated number of new lesions during the study and number of AK lesions that showed complete response 3 months after baseline. Secondary endpoints were number of BCC lesions that showed complete response, number of recurrent lesions, assessment of cosmetic outcome and safety.
NCT06014697
The increasing incidence of actinic keratosis (AK), morbus Bowen (MB) and cutaneous squamous cell carcinoma (cSCC), the patients with often multiple lesions and the disadvantages of invasive diagnostics show the need for an accurate non-invasive diagnostic tool for the determination of invasive growth in AK and MB. Optical coherence tomography (OCT) is a non-invasive scanner creating cross-sectional images of the skin, to a depth of 1-1,5 mm based on light waves. Until now, OCT has been proposed as non-invasive diagnostic tool for basal cell carcinomas. Although the diagnostic value of OCT for detection and sub-typing of basal cell carcinomas has already been demonstrated, it is unclear whether OCT can discriminate between invasive and non-invasive lesions (AK, MB and cSCCs). There are some studies that describe OCT characteristics of AK, MB and cSCCs, however, these characteristics have a lot of overlap (8-13). To date there are no clearly distinctive OCT features to distinguish between AK, MB and cSCCs. This study aims to investigate the value of OCT in discriminating between the presence and absence of invasion in lesions with clinical suspicion for invasion. Two experienced OCT-assessors will evaluate the OCT scans independently. The OCT assessors are blinded to the histological diagnosis of the lesions (invasive or non-invasive), which is used as golden standard. A 5-point Likert scale is used for OCT assessment. 1. Definitely not invasive 2. Probably not invasive 3. Unknown, probably invasive/probably not invasive 4. Probably invasive 5. Definitely invasive In addition to completing the Likert-scale, assessors are asked to describe the presence/absence of predefined OCT characteristics (a.o. hyperkeratosis and the presence of the dermo-epidermal junction) In case of disagreement between the independent assessors, the OCT scan will be re-assessed in a consensus meeting.
NCT01820260
To identify the Maximum Tolerated Dose levels of ingenol mebutate gel after once daily treatment for 2 or 3 consecutive days and to evaluate efficacy of ingenol mebutate gel in different doses after once daily treatment for 2 or 3 consecutive days compared to vehicle gel