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Patient Reported Outcomes Study Using Electronic Monitoring System for Advanced or Metastatic Solid Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Patient Reported Outcomes Study Using Electronic Monitoring System for Advanced or Metastatic Solid Cancer

Multicenter, Open-label, Randomized, Controlled Study to Test the Utility of Electronic Patient-reported Outcome (ePRO) Monitoring in Patients With Unresectable Advanced Cancers or Metastatic/Recurrent Solid Tumors

NCT05931445•Comprehensive Support Project for Oncology Research

View on ClinicalTrials.gov

Summary

This is a multicenter, open-label, randomized, controlled study to test the hypothesis that ePRO monitoring added to usual care helps prolong OS or maintain and improve HRQoL in patients with unresectable advanced cancers or metastatic/recurrent solid tumors receiving systemic drug therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Unresectable, advanced, metastasized, or relapsed solid tumors (Breast Cancer, Lung Cancer, Colorectal Cancer, Liver Cancer, Stomach Cancer, Endometrial Cancer, Ovarian Cancer, or Squamous Cell Carcinoma of the Head and Neck)
•2. Expected to be able to undergo treatment or observation for at least 6 months at the study site
•3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2
•4. Receiving systemic anticancer mono- or combination pharmacotherapy (e.g., cytotoxic anticancer agents, molecularly targeted drugs, and immune checkpoint inhibitors) at enrollment or scheduled to begin such therapy within 1 month from the date of enrollment (In principle, patients should be receiving pharmacotherapy on an out-patient basis.)
•5. Capable of using electronic device (includes cases needing some assistance)
•6. Aged 18 years or older at informed consent
•7. Written consent for the study personally obtained from the subject

Exclusion Criteria

•1. Has undergone four or more regimens of pharmacotherapy for advanced, metastasized, or relapsed solid tumors\*Notes 1, 2
•2. Currently participating in a study where PRO is tracked and the results are passed on to a physician
•* Scheduled to receive or currently receiving endocrine therapy (including endocrine therapy in combination with other agents) for hormone receptor-positive breast cancer
•* Scheduled to receive or currently receiving first regimen of anti-HER2 therapy for HER2-positive disease 2) Liver cancer
•* Hepatic function of Child-Pugh B/C
•4. Undergoing or scheduled to undergo radiation therapy for curative purposes
•5. Deemed otherwise unsuitable for the study by the investigator or sub-investigator
•* Notes:
•1. If the disease has relapsed during perioperative adjuvant chemotherapy or within 24 weeks after adjuvant chemotherapy, the adjuvant chemotherapy will be considered as the first regimen of adjuvant chemotherapy.
•2. Does not include endocrine therapy for breast cancer.

Locations (1)

Kobe University Graduate School

Kobe, Hyōgo, Japan

Key Dates

Start Date

January 26, 2021

Primary Completion Date

March 31, 2026

Completion Date

March 31, 2027

Last Updated

April 23, 2024

Enrollment

500

ESTIMATED participants

Conditions

Breast CancerLung CancerColorectal CancerLiver CancerStomach CancerEndometrial CancerOvarian CancerSquamous Cell Carcinoma of the Head and Neck

Interventions

e-PRO monitoring

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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: April 23, 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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Patient Reported Outcomes Study Using Electronic Monitoring System for Advanced or Metastatic Solid Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

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