Pan-tumor MRD Study
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: blood and tissue samples, blood and tissue samples.
- Who it may be relevant to
- Registry conditions: Muscle Invasive Bladder Urothelial Carcinoma, Esophageal Cancer, Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, Melanoma (Skin 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 →
Official title
Molecular Residual Disease in Solid Tumors: A Prospective Study to Collect Clinical Data and Biospecimens to Support Discovery and Development of Cancer Biomarkers
Overview
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.
Interventions
- Diagnostic test blood and tissue samples
routine standard of care - Other blood and tissue samples
Routine standard of care
Primary outcome measures
- Blood and tissue biospecimen registry [Time frame: Observation from enrollment to 5.5 years after enrollment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Medical Oncology Associates of San Diego — San Diego
- Taylor Cancer Research Center — Maumee
Identifiers
NCT: NCT06605404 · FH-PrwS-07-002