Collecting samples from patients with certain types of cancer to improve detection and treatment.
Molecular Residual Disease in Solid Tumors: A Prospective Study to Collect Clinical Data and Biospecimens to Support Discovery and Development of Cancer Biomarkers
This study is collecting blood and tissue samples from patients with certain types of cancer to see if it can help improve how we detect cancer and understand the risk of it coming back.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Paradigm Health Industry-sponsored |
| Locations | 2 sites (San Diego, California and 1 other locations) |
| Trial ID | NCT06605404 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather clinical information, blood, and tumor tissue samples from participants diagnosed with stage I, II, or operable stage III cancers, including muscle invasive bladder cancer, esophageal cancer, gastric and gastroesophageal junction adenocarcinoma, melanoma, and non-small cell lung cancer. Participants will receive standard care from their healthcare providers while contributing to the study over approximately 5.5 years. The collected data will be utilized to develop tests that enhance cancer detection and assess the risk of recurrence.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of specific solid tumors eligible for curative intent therapy.
Not a fit: Patients who have received systemic therapy for their current cancer diagnosis prior to enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for detecting cancer and understanding its recurrence risk.
How similar studies have performed: Other studies focusing on biospecimen collection and observational data have shown promise in improving cancer detection and treatment strategies.
Eligibility criteria
Show full inclusion / exclusion criteria
Eligibility Criteria:
1. Age 18 years or older.
2. 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).
3. 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.
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2.
5. No systemic therapy for current cancer diagnosis administered before enrollment.
6. Willing and able to comply with required study procedures, including blood sample collection and primary tumor tissue submission from diagnostic biopsy or surgical excision.
7. 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).
8. No concurrent diagnosis of another invasive cancer, except for nonmelanoma skin cancers.
9. No prior allogeneic hematopoietic stem cell transplant.
10. 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
11. Muscle-invasive urothelial carcinoma of the bladder and Melanoma Cohorts: Stage II or operable III cancer:
12. Esophageal, Gastric/GEJ, and NSCLC Cohorts: Stage I, II, or operable III cancer.
13. Pancreatic Cohort: Stage I, II or operable III cancer, exocrine only disease.
14. 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:
1. Central nervous system (CNS) malignancies
2. Colorectal cancer
3. Breast cancer
4. Squamous cell skin cancer
5. Basal cell carcinoma
6. Gastrointestinal stromal tumors (GIST)
7. Thyroid cancer
8. Uveal melanoma
9. 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
10. 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
Where this trial is running
San Diego, California and 1 other locations
- Medical Oncology Associates of San Diego — San Diego, California, United States (Recruiting)
- Taylor Cancer Research Center — Maumee, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Anosheh Afghahi, MD
- Email: anosheh.afghahi@flatiron.com
- Phone: 888-662-6367
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.