CAncer TReatment INformed by the Molecular Tumor Board At Dartmouth (CATRINA)

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: Treatment recommendations made by Molecular Tumor Board.

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Laura J Tafe, MD; Phone Number: (603) 650-7211; Email: laura.j.tafe@hitchcock.org
• Study Contact Backup: Name: Jacob R Dubien; Email: jacob.r.dubien@Hitchcock.org

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Recruiting
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects evaluated by Molecular Tumor Board; Subjects whose cases are evaluated by Molecular Tumor Board	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects for whom evaluation by Molecular Tumor Board impacts treatment decisions as reported by the treating physician.	Treating physicians will complete surveys at 3 months after Molecular Tumor Board recommendations are made. Survey response from the treating physician indicating how Molecular Tumor Board recommendations impacted treatment decisions.	3 months after recommendation
Proportion of subjects for whom evaluation by Molecular Tumor Board impacts treatment decisions as reported by the treating physician.	Treating physicians will complete surveys at 12 months after Molecular Tumor Board recommendations are made. Survey response from the treating physician indicating how Molecular Tumor Board recommendations impacted treatment decisions.	12 months after recommendation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects for whom Molecular Tumor Board recommends treatment with a tumor-targeted therapy or immunotherapy.	Proportion of subjects for whom a tumor-targeted therapy or immunotherapy (i.e., not conventional chemotherapy) made by the Molecular Tumor Board will be collected.	1 month after recommendation
Proportion of subjects who are treated with a Molecular Tumor Board-recommended tumor-targeted therapy or immunotherapy	Proportion of subjects who are treated with a Molecular Tumor Board-recommended tumor-targeted therapy or immunotherapy	Approximately 3 months after recommendation
Number of participants with progression-free survival after Molecular Tumor Board recommendations were made.	Subjects' disease outcomes will be followed for up to 36 months following the date of Molecular Tumor Board recommendations. Progression-free survival is defined as the time from start of treatment to disease progression or death from any cause.	Up to 36 months after recommendation
Time to treatment failure	Time to treatment failure is defined as the time from start of treatment to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.	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.	Determine the proportion of subjects for whom Molecular Tumor Board-recommended germline genetic testing results in confirmation of a germline genetic lesion/mutation.	Approximately 3 months after recommendation

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2024
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Estimated): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: STUDY02001441; NCI-2024-03404 (Other Identifier: NCI); 22TAF441 (Other Identifier: Dartmouth Hitchcock)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No