ACTIVE_NOT_RECRUITING

Studying Pathways of Resistance in KRAS-driven Cancers

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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

Up to 250 patients from anywhere in the United States can remotely consent and participate to have plasma drawn locally and submitted to Foundation Medicine, Inc. (FMI), for the FoundationOne® Liquid Biopsy Assay. Patients who have had resistance mechanisms determined through other assays can also consent to share these data. The Investigator(s) will compare mechanisms of acquired resistance across drugs (e.g. sotorasib vs adagrasib) and between tumor types (e.g. NSCLC vs CRC) to determine if different resistance mutations arise in these settings.

Official Title

A Non-interventional, Non-treatment, Non-randomized, Single Coordinating Center, Decentralized Bio-specimen Collection Study in USA-based Adult Subjects With Acquired Resistance to KRAS Inhibitors

Quick Facts

Study Start:2022-09-08

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05272423

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
* Cohort 1A- Liquid Biopsy 1. Participants older than 18 years old at the time of consent or age of majority for residential state. 2. Demonstration of having advanced KRAS G12C positive cancer. 3. Systemic progression (not CNS only progression) within the past 30 days, having previously been treated with a therapeutic, targeting the specific KRAS mutation. 4. Patient must not have started a new line of therapy before signing the informed consent form. 5. Willingness to provide a blood specimen prior to the initiation of a new line of treatment. 6. Willingness to provide clinical and medical information to the study team as required. 7. Ability to read, write and communicate in English. 8. Ability to sign a web-based informed consent form. 1. Participants older than 18 years old at the time of consent or age of majority for residential state. 2. Demonstration of having advanced KRAS G12C positive cancer. 3. Systemic progression (not CNS only progression) after being treated with a therapeutic targeting the specific KRAS mutation. 4. Patient must have prior tumor genotyping available (tissue or plasma) after progression on therapeutic targeting the specific KRAS mutation. 5. Willingness to provide clinical and medical information to the study team as required. 6. Ability to read, write and communicate in English. 7. Ability of the participant or legally authorized representative (LAR) to sign a web-based informed consent form.	1. Participants who are unable to comply with the study procedures. 2. Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements. 3. Participants who have previously enrolled to the study.

Inclusion Criteria

Exclusion Criteria

* Cohort 1A- Liquid Biopsy
1. Participants older than 18 years old at the time of consent or age of majority for residential state.
2. Demonstration of having advanced KRAS G12C positive cancer.
3. Systemic progression (not CNS only progression) within the past 30 days, having previously been treated with a therapeutic, targeting the specific KRAS mutation.
4. Patient must not have started a new line of therapy before signing the informed consent form.
5. Willingness to provide a blood specimen prior to the initiation of a new line of treatment.
6. Willingness to provide clinical and medical information to the study team as required.
7. Ability to read, write and communicate in English.
8. Ability to sign a web-based informed consent form.
1. Participants older than 18 years old at the time of consent or age of majority for residential state.
2. Demonstration of having advanced KRAS G12C positive cancer.
3. Systemic progression (not CNS only progression) after being treated with a therapeutic targeting the specific KRAS mutation.
4. Patient must have prior tumor genotyping available (tissue or plasma) after progression on therapeutic targeting the specific KRAS mutation.
5. Willingness to provide clinical and medical information to the study team as required.
6. Ability to read, write and communicate in English.
7. Ability of the participant or legally authorized representative (LAR) to sign a web-based informed consent form.

1. Participants who are unable to comply with the study procedures.
2. Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements.
3. Participants who have previously enrolled to the study.

Contacts and Locations

Study Locations (Sites)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Addario Lung Cancer Medical Institute

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 Date2022-09-08

Study Completion Date2026-03

Study Record Updates

Study Start Date2022-09-08

Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

KRAS P.G12C