CAncer TReatment INformed by the Molecular Tumor Board At Dartmouth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-19

Study Completion Date

2029-12-31

Brief Summary

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This is a single-arm Phase II study to measure the impact of Molecular Tumor Board treatment recommendations on treatment decision-making in clinical practice at the Dartmouth Cancer Center. Following tumor genetic profiling, subjects will be screened for eligibility. Eligible subjects' cases will be evaluated by the Dartmouth Cancer Center Molecular Tumor Board, and treatment recommendations will be entered into the medical record as per standard procedure.

The primary endpoint is a survey response from the treating physician indicating how Molecular Tumor Board evaluation impacted treatment decisions. Secondary endpoints include: 1) Molecular Tumor Board treatment recommendation; 2) disease progression on line of therapy started after MTB recommendations were made. Surveys will be administered approximately 3 and 12 months after Molecular Tumor Board recommendations are made.

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Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subjects evaluated by Molecular Tumor Board

Subjects whose cases are evaluated by Molecular Tumor Board

Group Type EXPERIMENTAL

Treatment recommendations made by Molecular Tumor Board.

Intervention Type OTHER

Molecular Tumor Board recommendations may include any of the following:

(A) a tumor-targeted drug (alone or in combination)

(B) an antibody-based immunotherapy (alone or in combination)

(C) neither (A) nor (B).

(D) referral to the Familial Cancer Program

(E) referral for germline genetic testing

Interventions

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Treatment recommendations made by Molecular Tumor Board.

Molecular Tumor Board recommendations may include any of the following:

(A) a tumor-targeted drug (alone or in combination)

(B) an antibody-based immunotherapy (alone or in combination)

(C) neither (A) nor (B).

(D) referral to the Familial Cancer Program

(E) referral for germline genetic testing

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject must provide verbal informed consent for study participation prior to MTB case evaluation.
* Tumor genetic profiling performed as standard of care must include ≥100 genes.
* Tumor must contain at least one of the following genetic alterations: (A) an alteration known to be potentially associated with sensitization to a clinically available treatment. (the list of genetic alterations evolves as new information emerges and new drugs are developed); (B) an alteration suspected to be germline.
* Subject must have ECOG Performance Status of 0 to 2.
* Subject must have measurable or evaluable disease.
* Subjects who have previously enrolled in this study can be enrolled a second time if they undergo genetic profiling of a tumor that was biopsied/sampled AFTER progression on an intervening line of treatment started after the time of first enrollment. Re-enrollment of such subjects must be noted in REDCap to facilitate longitudinal analysis.
* Age ≥18 years.

Exclusion Criteria

* Subjects with a tumor harboring a genetic alteration for which an FDA-approved drug is indicated that the patient has not yet received (example for exclusion: a melanoma with a BRAF-V600E mutation in a subject who has not yet been treated with a BRAF inhibitor).
* Pregnant women.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No