Pan-tumor MRD Study
Molecular Residual Disease in Solid Tumors: A Prospective Study to Collect Clinical Data and Biospecimens to Support Discovery and Development of Cancer Biomarkers
The purpose of this observational study is to collect clinical information, blood, and tumor tissue samples from participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors. The information collected will be used to develop tests to better understand cancer, for example, to improve cancer detection and to assess the risk of cancer coming back.
Participants will receive routine standard of care from their doctor and their involvement is expected to last for approximately five and a half (5.5) years.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Anosheh Afghahi, MD
- Phone Number: 888-662-6367
- Email: anosheh.afghahi@flatiron.com
Study Locations
-
-
California
-
San Diego, California, United States, 92123
- Recruiting
- Medical Oncology Associates of San Diego
-
Contact:
- Alexis Bustamante
- Email: abustamante@oncologysandiego.com
-
-
Ohio
-
Maumee, Ohio, United States, 43437
- Recruiting
- Taylor Cancer Research Center
-
Contact:
- Jennifer Martinez
- Phone Number: ext 4134 419-479-5605
- Email: jmartinez@toledoclinic.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Eligibility Criteria:
- Age 18 years or older.
- Confirmed histological or cytological diagnosis of a malignant solid tumor that is either specified in one of the pre-defined tumor cohorts or meets the enrollment criteria for the Mix of Solid Tumors (MOST) cohort (Table 1).
Eligible for curative intent therapy, with surgical resection of cancer planned.
a. If surgical resection has occurred, enrollment should occur within 3 months of surgical resection and before initiation of adjuvant therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2.
- No systemic therapy for current cancer diagnosis administered before enrollment.
- Willing and able to comply with required study procedures, including blood sample collection and primary tumor tissue submission from diagnostic biopsy or surgical excision.
- Has completed all therapy (including endocrine therapy) 3 or more years ago for any previous invasive solid organ malignancy (with exception of nonmelanoma skin cancers) or hematologic malignancy. Individuals with a prior history of noninvasive (in situ) carcinomas may participate if they have received definitive treatment (no washout period required).
- No concurrent diagnosis of another invasive cancer, except for nonmelanoma skin cancers.
- No prior allogeneic hematopoietic stem cell transplant.
Able and willing to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information.
Cohort Specific Criteria
- Muscle-invasive urothelial carcinoma of the bladder and Melanoma Cohorts: Stage II or operable III cancer:
- Esophageal, Gastric/GEJ, and NSCLC Cohorts: Stage I, II, or operable III cancer.
- Pancreatic Cohort: Stage I, II or operable III cancer, exocrine only disease.
- MOST cohort: Stage II or operable stage III solid tumor diagnosis that meets eligibility criteria and is not included in the other cohorts.
The following tumor types are excluded:
- Central nervous system (CNS) malignancies
- Colorectal cancer
- Breast cancer
- Squamous cell skin cancer
- Basal cell carcinoma
- Gastrointestinal stromal tumors (GIST)
- Thyroid cancer
- Uveal melanoma
Low or intermediate grade neuroendocrine tumors
■ Eligible tumor types: High-grade neuroendocrine tumors, including neuroendocrine carcinomas, Merkel cell carcinomas, and small cell lung cancer are permissible
- Hematologic cancers including multiple myeloma or other plasma cell dyscrasias, Hodgkin's lymphoma, non-Hodgkin's lymphoma, acute or chronic leukemias including chronic lymphocytic leukemia / small lymphocytic leukemia
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC)
|
routine standard of care
Routine standard of care
|
|
Esophageal
Esophageal cancer
|
routine standard of care
Routine standard of care
|
|
Gastric and Gastroesophageal Junction (GEJ)
|
routine standard of care
Routine standard of care
|
|
Melanoma
|
routine standard of care
Routine standard of care
|
|
Non-small cell lung (NSCLC)
|
routine standard of care
Routine standard of care
|
|
Pancreatic (exocrine only)
|
routine standard of care
Routine standard of care
|
|
Mix of Solid Tumors (MOST)
|
routine standard of care
Routine standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood and tissue biospecimen registry
Time Frame: Observation from enrollment to 5.5 years after enrollment
|
To establish a blood and tissue biospecimen resource in participants with operable solid tumors, with clinical, lab, radiographic, and pathology annotation for the discovery, development, and validation of MRD assays.
|
Observation from enrollment to 5.5 years after enrollment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FH-PrwS-07-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
product manufactured in and exported from the U.S.
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