Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
a study on Acute Lymphoblastic Leukemia Leukemia Acute Myeloid Leukemia Lymphoma Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Gastroesophageal Junction Adenocarcinoma Gastroesophageal Junction Cancer Head and Neck Cancer Hematopoietic and Lymphoid Cell Neoplasm Breast Cancer Kidney Cancer Hepatobiliary Neoplasm Solid Neoplasm Skin Cancer/Melanoma Bladder Cancer Multiple Myeloma Sarcoma Colorectal Cancer Esophageal Cancer Stomach Cancer Lung Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer Uterine Cancer Thyroid Cancer Carcinoma Lung Tumor Neoplasms Colorectal Tumor Pancreatic Neoplasms Ovarian Epithelial Carcinoma Urinary Bladder Tumor Renal Cell Carcinoma Kidney Neoplasm
Summary
- Eligibility
- for people ages 40-75 (full criteria)
- Healthy Volunteers
- healthy people welcome
- Location
- at UC Davis
- Dates
- study startedcompletion around
- Principal Investigator
- by Shahzad Siddique (ucdavis)
Description
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.
Official Title
Blinded Reference Set for Multicancer Early Detection Blood Tests
Details
PRIMARY OBJECTIVE:
- 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:
- 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.
Keywords
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Ann Arbor Stage I Lymphoma, Ann Arbor Stage II Lymphoma, Ann Arbor Stage III Lymphoma, Ann Arbor Stage IV Lymphoma, Chronic Lymphocytic Leukemia, Chronic Myeloid Leukemia, Gastroesophageal Junction Adenocarcinoma, Head and Neck Carcinoma, Hematopoietic and Lymphoid Cell Neoplasm, Invasive Breast Carcinoma, Kidney Carcinoma, Malignant Hepatobiliary Neoplasm, Malignant Solid Neoplasm, Melanoma, Muscle-Invasive Bladder Carcinoma, RISS Stage I Plasma Cell Myeloma, RISS Stage II Plasma Cell Myeloma, RISS Stage III 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 Esophageal Cancer AJCC V7, Stage I Gastric Cancer AJCC 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, Thyroid Gland Carcinoma, Lymphoma, Carcinoma, Breast Neoplasms, Leukemia, Lung Neoplasms, Prostatic Neoplasms, Neoplasms, Colorectal Neoplasms, Myeloid Leukemia, Multiple Myeloma, Plasma Cell Neoplasms, Pancreatic Neoplasms, Ovarian Neoplasms, Ovarian Epithelial Carcinoma, Stomach Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Urinary Bladder Neoplasms, Esophageal Neoplasms, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Thyroid Neoplasms, Renal Cell Carcinoma, Kidney Neoplasms, Biospecimen Collection
Eligibility
For people ages 40-75
Inclusion Criteria:
- Participants with a cancer diagnosis: Documentation of disease:
- Histologic documentation: Histologically confirmed diagnosis of invasive cancer
Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma
- For leukemia: Type (chronic lymphocytic leukemia [CLL], chronic myeloid leukemia [CML], acute lymphoblastic lymphoma [ALL], acute myeloid leukemia [AML]) - For lymphoma: Stage I-IV based on Ann Arbor staging - For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS)
One of the following tumor types:
- Colorectal - Bladder - Head and neck - Hepatobiliary - Lung - Lymphoma - Leukemia - Ovary *** For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment - Pancreas *** For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment - Multiple myeloma - Gastric, esophageal or gastroesophageal - Breast - Thyroid - Kidney - For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment - Endometrium - Prostate - Melanoma *** For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment - Sarcoma
- Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention
- Participants with a cancer diagnosis: Age >= 40 and =< 75
- Participants with a cancer diagnosis: No known current pregnancy by self-report
- Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis
- Participants with a cancer diagnosis: Willingness to provide blood samples for research use
- Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL
- Participants with a cancer diagnosis: No history of organ transplantation
- Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish
- Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages
- Participants without a cancer diagnosis and without suspicion of cancer: Age >= 40 and =< 75
- Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report
- Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)
- Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use
- Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL
- Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation
- Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish
- Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages
- Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and/or radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw
- Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma
- Participants with a high suspicion of cancer: Central review of radiology reports and/or clinical documentation conducted by study chairs
- Participants with a high suspicion of cancer: Age >= 40 and =< 75
- Participants with a high suspicion of cancer: No known current pregnancy by self-report
- Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis
- Participants with a high suspicion of cancer: Willingness to provide blood samples for research use
- Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL
- Participants with a high suspicion of cancer: No history or organ transplantation
- Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish * Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages
Locations
- Mercy UC Davis Cancer Center
accepting new patients
Merced California 95340 United States - Providence Saint Joseph Medical Center/Disney Family Cancer Center
accepting new patients
Burbank California 91505 United States - Bay Area Breast Surgeons Inc
accepting new patients
Emeryville California 94608 United States - Epic Care Partners in Cancer Care
accepting new patients
Emeryville California 94608 United States - Woodland Memorial Hospital
accepting new patients
Woodland California 95695 United States - Bay Area Tumor Institute
accepting new patients
Oakland California 94609 United States - Mercy Cancer Center - Sacramento
accepting new patients
Sacramento California 95816 United States - Mercy Cancer Center - Elk Grove
accepting new patients
Elk Grove California 95758 United States - Tibor Rubin VA Medical Center
accepting new patients
Long Beach California 90822 United States - Contra Costa Regional Medical Center
accepting new patients
Martinez California 94553-3156 United States
Lead Scientist at University of California Health
- Shahzad Siddique (ucdavis)
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Alliance for Clinical Trials in Oncology
- ID
- NCT05334069
- Study Type
- Observational
- Participants
- Expecting 2000 study participants
- Last Updated