CAncer TReatment INformed by the Molecular Tumor Board At Dartmouth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treatment recommendations made by Molecular Tumor Board..
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other 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
Primary outcome measures
- Proportion of subjects for whom evaluation by Molecular Tumor Board impacts treatment decisions as reported by the treating physician. [Time frame: 3 months after recommendation]
- Proportion of subjects for whom evaluation by Molecular Tumor Board impacts treatment decisions as reported by the treating physician. [Time frame: 12 months after recommendation]
Secondary outcome measures (5)
- Proportion of subjects for whom Molecular Tumor Board recommends treatment with a tumor-targeted therapy or immunotherapy. [Time frame: 1 month after recommendation]
- Proportion of subjects who are treated with a Molecular Tumor Board-recommended tumor-targeted therapy or immunotherapy [Time frame: Approximately 3 months after recommendation]
- Number of participants with progression-free survival after Molecular Tumor Board recommendations were made. [Time frame: Up to 36 months after recommendation]
- Time to treatment failure [Time frame: Up to 36 months after recommendation]
- Proportion of subjects for whom Molecular Tumor Board-recommended germline genetic testing results in confirmation of a germline genetic lesion/mutation. [Time frame: Approximately 3 months after recommendation]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Dartmouth-Hitchcock Medical Center — Lebanon
Identifiers
NCT: NCT05405413 · STUDY02001441 · NCI-2024-03404 · 22TAF441