COMPLETED

Screening Study for Participants With Malignant Tumors

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study objective is to determine the biomarker status of a participant's tumor tissue and use that status to determine eligibility for a linked Roche clinical trial.

Official Title

Master Screening Study to Determine Biomarker Status and Potential Trial Eligibility for Patients With Malignant Tumors

Quick Facts

Study Start:2022-07-22

Study Completion:2025-09-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05419375

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Confirmed availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen meeting criteria defined in the protocol * Considered by principal investigator (PI) to be a candidate for a linked clinical trial with an investigational medicinal product, and that the participant has the awareness and willingness to participate in said trial * Locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology based on 8th edition of the American Joint Committee on Cancer (AJCC) and Union for International Cancer Control (UICC) cancer staging system * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 * Stage II, IIIA, or select IIIB (T3N2 only) NSCLC based on the 8th edition of the AJCC and UICC cancer staging system (Amin et al. 2017) * Considered eligible for curative intent surgery (complete resection with all surgical margins testing negative for tumor) * Screening within Study BX43361, using a pretreatment biopsy, is encouraged to be performed as early in the participant treatment pathway as possible to ensure the participant is potentially eligible for all cohorts, and should meet guidelines as defined by the protocol * Representative FFPE tumor specimen obtained prior to the start of any treatment * ECOG Performance Status of 0 or 1	* History of malignancy other than NSCLC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death * Any condition that may affect the interpretation of study results * Significant liver or cardiovascular disease * Prior allogenic stem-cell or solid-organ transplantation

Inclusion Criteria

Exclusion Criteria

* Confirmed availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen meeting criteria defined in the protocol
* Considered by principal investigator (PI) to be a candidate for a linked clinical trial with an investigational medicinal product, and that the participant has the awareness and willingness to participate in said trial
* Locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology based on 8th edition of the American Joint Committee on Cancer (AJCC) and Union for International Cancer Control (UICC) cancer staging system
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Stage II, IIIA, or select IIIB (T3N2 only) NSCLC based on the 8th edition of the AJCC and UICC cancer staging system (Amin et al. 2017)
* Considered eligible for curative intent surgery (complete resection with all surgical margins testing negative for tumor)
* Screening within Study BX43361, using a pretreatment biopsy, is encouraged to be performed as early in the participant treatment pathway as possible to ensure the participant is potentially eligible for all cohorts, and should meet guidelines as defined by the protocol
* Representative FFPE tumor specimen obtained prior to the start of any treatment
* ECOG Performance Status of 0 or 1

* History of malignancy other than NSCLC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death
* Any condition that may affect the interpretation of study results
* Significant liver or cardiovascular disease
* Prior allogenic stem-cell or solid-organ transplantation

Contacts and Locations

Principal Investigator

Clinical Trials

STUDY_DIRECTOR

Hoffmann-La Roche

Study Locations (Sites)

Thompson Cancer Survival Center

Knoxville, Tennessee, 37916-2305

United States

Texas Oncology, P.A.

Austin, Texas, 78745

United States

Texas Oncology- Northeast Texas

Tyler, Texas, 75702

United States

Oncology & Hematology Associates of Southwest Virginia, Inc

Blacksburg, Virginia, 24060

United States

Northwest Cancer Specialists

Vancouver, Washington, 98686

United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-22

Study Completion Date2025-09-03

Study Record Updates

Study Start Date2022-07-22

Study Completion Date2025-09-03

Terms related to this study

Additional Relevant MeSH Terms

Solid Tumors