Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-03404 | Other Identifier | NCI | |
| 22TAF441 | Other Identifier | Dartmouth Hitchcock |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects evaluated by Molecular Tumor Board | Experimental | Subjects whose cases are evaluated by Molecular Tumor Board |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment recommendations made by Molecular Tumor Board. | 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 |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura J Tafe, MD | Contact | (603) 650-7211 | laura.j.tafe@hitchcock.org | |
| Jacob R Dubien | Contact | jacob.r.dubien@Hitchcock.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |