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Development of a Cell Free DNA Assay as a Biomarker for Predicting Early Non-response to Therapy in Metastatic Cancer | Clinical Trials | Clareo Health

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Development of a Cell Free DNA Assay as a Biomarker for Predicting Early Non-response to Therapy in Metastatic Cancer

NCT03892096•Cadex Genomics

View on ClinicalTrials.gov

Summary

Accrue samples for the further development and clinical validation of a blood-based cell-free DNA (cfDNA) quantitative real-time polymerase chain reaction (qPCR) assay as a potential biomarker for early non-response to therapy in stage IV non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and breast cancer (BC).

Detailed Description

Most anticancer drugs are effective only in subgroups of patients, and our current understanding of tumor biology does not allow us to predict accurately which patient will benefit from a specific therapeutic regimen. The definitive proof of the effectiveness of a therapy is improvement in clinical symptoms and survival. Imaging is generally used to assess therapeutic effects earlier and more objectively. Current response assessment is based primarily on changes in tumor size as measured by CT or other anatomic imaging modalities. Cadex Genomics has developed an analytically validated cell-free DNA (cfDNA) quantitative real-time polymerase chain reaction (qPCR) assay that utilizes standard qPCR platforms for processing, this test can reliably obtain results from small blood volumes and possesses exceptionally high analytical sensitivity of circulating cfDNA. The purpose of this study is to accrue samples for the further development and clinical validation of a blood-based cell-free cfDNA qPCR assay as a potential biomarker for early non-response to therapy in stage IV non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and breast cancer (BC).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years.
•Documented stage IV NSCLC, SCLC, BC or CRC (can be new diagnosis, persistent or recurrent disease):
•BC patients who meet the following criteria:
•ER+/HER2- and has failed hormone therapy within the last two years, or ER+/HER2+ or, ER-/HER+ or, HER2-/ER-/PR- (TNBC), and Has ≥ 1 measurable non- bone lesion as measured per RECIST or, If bone only disease, has two or more measurable (\> 1 cm by RECIST) predominantly lytic bone lesions
•Planned initiation of new systemic first- or second-line treatment or subsequent therapies with chemotherapy, immunotherapy, targeted therapy or combination thereof. Or continuation of the current line of therapy after RECIST/iRECIST evaluation which coincides with end of the cycle of therapy and prior to initiation of the next cycle of therapy.
•Imaging to determine RECIST and/or iRECIST criteria:
•If baseline blood draw is planned prior to first cycle of a line (1st, 2nd, 3rd etc) of therapy, measurable disease with CT or MRI or PET/CT monitoring should be completed within 4 weeks prior to baseline blood draw.
•If baseline test is performed at the completion of a cycle of therapy, CT or MRI or PET/CT monitoring should be completed to coincide with end of cycle of therapy and prior to baseline blood draw.
•Planned CT or MRI or PET/CT monitoring for treatment response completed within 8-12 weeks of start of treatment.
•Willing and able to donate up to 30mL of blood at each blood draw. Willing and able to provide informed consent.

Exclusion Criteria

•Diagnosis of a secondary malignancy that is not in complete remission. Imaging to determine RECIST and/or iRECIST criteria is not planned or available.
•CT or MRI or PET/CT monitoring for treatment response is not planned within 8-12 weeks.
•Presence of active autoimmune disease which is under active treatment. DVT, PE, sepsis, or has recovered from any other serious illness within the prior 2 weeks of the baseline blood draw. (Note: Patients who have recovered from similar conditions more than 2 weeks prior to the baseline blood draw would be eligible for the study) If initiating a new line of therapy, patient has received any doses of the new block of therapy before the first designated blood draw.
•If continuing current line of therapy after CT, MRI or PET/CT monitoring, patient has received subsequent cycle of therapy before the first designated blood draw.
•Performance status ECOG ≥3. Evidence of acute renal failure as determined by current clinical guidelines. NSCLC, SCLC or CRC patients beyond 9 months of the initiation of therapy, on 1st line immunotherapy alone, or combination immunotherapy and chemotherapy regimens. (Note: patients on subsequent lines of therapy (2nd,3rd line etc.) would be eligible at any time point including prior to the 9 months vs those patients on 1st line therapy)..

Locations (12)

CARTI Cancer Center

Little Rock, Arkansas, United States

Sutter Health - Palo Alto Medical Foundation

Sunnyvale, California, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

IACT Health

Columbus, Georgia, United States

University Medical Center

New Orleans, Louisiana, United States

Southeast Louisiana Veterans Health Care System

New Orleans, Louisiana, United States

Nebraska Cancer Center

Omaha, Nebraska, United States

National Translational Research Group LLC

Port Jefferson Station, New York, United States

Waverly Hematology Oncology

Cary, North Carolina, United States

Advent Health

Hendersonville, North Carolina, United States

Key Dates

Start Date

March 1, 2019

Primary Completion Date

November 15, 2023

Completion Date

February 6, 2024

Last Updated

February 7, 2024

Enrollment

130

ACTUAL participants

Conditions

Metastatic Non-Small Cell Lung CarcinomaMetastatic Colorectal CancerMetastatic Breast Cancer

Interventions

Blood-based cell-free cfDNA qPCR assay

DIAGNOSTIC_TEST

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Development of a Cell Free DNA Assay as a Biomarker for Predicting Early Non-response to Therapy in Metastatic Cancer

Inclusion Criteria

Exclusion Criteria

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