Molecular Residual Disease in Solid Tumors: A Prospective Study to Collect Clinical Data and Biospecimens to Support Discovery and Development of Cancer Biomarkers

Paradigm Health49 个研究点分布在 1 个国家目标入组 1,350 人开始时间: 2025年1月8日最近更新: 2026年9月24日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 1,350
试验地点: 49
主要终点: Blood and tissue biospecimen registry

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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
•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

排除标准

未提供