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Clinical Trial Summary

This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To provide a blinded reference set of cancer versus (vs.) non-cancer blood samples that will be used to validate assays for inclusion in a prospective clinical trial focused on utility of blood-based multi-cancer early detection. SECONDARY OBJECTIVES: I. Evaluate test performance at the time of initial cancer diagnosis by tumor type. II. Evaluate test performance at the time of initial cancer diagnosis by clinical stage. OUTLINE: Participants complete a questionnaire at baseline. Participants undergo collection of blood samples at registration and at 12 months after registration. Patients with a cancer diagnosis may undergo collection of tissue samples at registration and 12 months after registration. After completion of study, participants are followed up at 1 year. ;


Study Design


Related Conditions & MeSH terms

  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Ann Arbor Stage III Lymphoma
  • Ann Arbor Stage IV Lymphoma
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Ovarian Epithelial
  • Carcinoma, Renal Cell
  • Chronic Lymphocytic Leukemia
  • Chronic Myeloid Leukemia
  • Colorectal Neoplasms
  • Esophageal Neoplasms
  • Gastroesophageal Junction Adenocarcinoma
  • Head and Neck Carcinoma
  • Hematopoietic and Lymphoid Cell Neoplasm
  • Invasive Breast Carcinoma
  • Kidney Carcinoma
  • Kidney Neoplasms
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid
  • Lung Neoplasms
  • Lymphoma
  • Malignant Hepatobiliary Neoplasm
  • Malignant Solid Neoplasm
  • Melanoma
  • Multiple Myeloma
  • Muscle-Invasive Bladder Carcinoma
  • Neoplasms
  • Neoplasms, Plasma Cell
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Prostatic Neoplasms
  • RISS Stage I Plasma Cell Myeloma
  • RISS Stage II Plasma Cell Myeloma
  • Sarcoma
  • Stage I Bladder Cancer AJCC v6 and v7
  • Stage I Breast Cancer AJCC v7
  • Stage I Colorectal Cancer AJCC v6 and v7
  • Stage I Lung Cancer AJCC v7
  • Stage I Ovarian Cancer AJCC v6 and v7
  • Stage I Pancreatic Cancer AJCC v6 and v7
  • Stage I Prostate Cancer AJCC v7
  • Stage I Uterine Corpus Cancer AJCC v7
  • Stage II Bladder Cancer AJCC v6 and v7
  • Stage II Breast Cancer AJCC v6 and v7
  • Stage II Colorectal Cancer AJCC v7
  • Stage II Esophageal Cancer AJCC v7
  • Stage II Gastric Cancer AJCC v7
  • Stage II Lung Cancer AJCC v7
  • Stage II Ovarian Cancer AJCC v6 and v7
  • Stage II Pancreatic Cancer AJCC v6 and v7
  • Stage II Prostate Cancer AJCC v7
  • Stage II Uterine Corpus Cancer AJCC v7
  • Stage III Bladder Cancer AJCC v6 and v7
  • Stage III Breast Cancer AJCC v7
  • Stage III Colorectal Cancer AJCC v7
  • Stage III Esophageal Cancer AJCC v7
  • Stage III Gastric Cancer AJCC v7
  • Stage III Lung Cancer AJCC v7
  • Stage III Ovarian Cancer AJCC v6 and v7
  • Stage III Pancreatic Cancer AJCC v6 and v7
  • Stage III Prostate Cancer AJCC v7
  • Stage III Uterine Corpus Cancer AJCC v7
  • Stage IV Bladder Cancer AJCC v7
  • Stage IV Breast Cancer AJCC v6 and v7
  • Stage IV Colorectal Cancer AJCC v7
  • Stage IV Esophageal Cancer AJCC v7
  • Stage IV Gastric Cancer AJCC v7
  • Stage IV Lung Cancer AJCC v7
  • Stage IV Ovarian Cancer AJCC v6 and v7
  • Stage IV Pancreatic Cancer AJCC v6 and v7
  • Stage IV Prostate Cancer AJCC v7
  • Stage IV Uterine Corpus Cancer AJCC v7
  • Stomach Neoplasms
  • Thyroid Gland Carcinoma
  • Thyroid Neoplasms
  • Urinary Bladder Neoplasms

NCT number NCT05334069
Study type Observational
Source Alliance for Clinical Trials in Oncology
Contact Marie Wood, MD
Phone (720) 848-0300
Email marie.wood@cuanschutz.edu
Status Recruiting
Phase
Start date August 1, 2022
Completion date February 2025

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