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Trial record 3 of 3 for:    Flatiron health

Prospective Clinicogenomic Program (PCG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04180176
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : May 14, 2020
Sponsor:
Collaborator:
Flatiron Health, Inc.; Foundation Medicine, Inc.
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
The main purpose of this study is to evaluate the feasibility of a scalable, prospective research program for participants with metastatic non-small cell lung cancer (mNSCLC) or extensive-stage small-cell lung cancer (ES-SCLC) planning to start standard-of-care (SOC) systemic anti-cancer treatment. The study will also examine ctDNA status over the course of treatment as a predictor of response to therapy.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer (NSCLC) Small-Cell Lung Cancer (SCLC) Other: Blood Draw Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Multicenter, Low-Interventional Study to Evaluate the Feasibility of a Prospective Clinicogenomic Program
Actual Study Start Date : December 13, 2019
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A
Participants with mNSCLC or ES-SCLC will give blood samples at three separate timepoints for ctDNA profiling.
Other: Blood Draw
Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy.




Primary Outcome Measures :
  1. Proportion of Potential Eligible Participant Enrollment [ Time Frame: Up to 5 years ]
  2. Proportion of Enrolled Participants Submitting Sufficient Blood Samples [ Time Frame: At enrollment, then at pre-defined intervals from the first tumor assessment until disease assessment or end of therapy, whichever comes first, for up to 5 years. ]

Secondary Outcome Measures :
  1. Blood Level of ctDNA [ Time Frame: At enrollment, then at pre-defined intervals from the first tumor assessment until disease assessment or end of therapy, whichever comes first, for up to 5 years. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of mNSCLC or ES-SCLC
  • Planned initiation of SOC systemic anti-cancer treatment

Exclusion Criteria:

- Participation in an interventional trial at the time of signing informed consent


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04180176


Contacts
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Contact: Reference Study ID Number: GX41563 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
Show Show 18 study locations
Sponsors and Collaborators
Genentech, Inc.
Flatiron Health, Inc.; Foundation Medicine, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT04180176    
Other Study ID Numbers: GX41563
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com).

Further details on Roche's criteria for eligible studies are available here: https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here: (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms