Collecting Blood Samples From Patients With And Without Cancer To Evaluate Tests For Early Cancer Detection

Study Overview

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

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.

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.

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

OTHER: Questionnaire Administration
PROCEDURE: Biospecimen Collection

A212102
NCI-2022-02477 (REGISTRY Identifier) (REGISTRY: NCI Clinical Trial Reporting Program)
UG1CA189823 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-04-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-03-28
First Submitted that Met QC Criteria 2022-04-12	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-03-30
First Posted (ACTUAL) 2022-04-19	Results First Posted N/A	Last Verified 2025-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Screening (questionnaire, biospecimen collection) 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 month	OTHER: Questionnaire Administration Complete questionnaire PROCEDURE: Biospecimen Collection Undergo collection of tissue and blood samples

Participant Group/Arm

Intervention/Treatment

: Screening (questionnaire, biospecimen collection)

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 month

OTHER: Questionnaire Administration

Complete questionnaire

PROCEDURE: Biospecimen Collection

Undergo collection of tissue and blood samples

Primary Outcome Measures	Measure Description	Time Frame
Provision of blinded reference set of cancer versus non-cancer blood samples	Diagnostic ability will be assessed across the entire cohort of 2000 subjects by estimating the sensitivity and specificity with 95% confidence intervals.	Up to 1 year

Secondary Outcome Measures	Measure Description	Time Frame
Test performance at the time of initial cancer diagnosis by tumor type	Diagnostic ability is assessed within each cancer type and within each cancer type and stage combination by estimating the sensitivity and specificity with 95% confidence intervals. The width of these confidence intervals will vary by sample size and the sensitivity and specificity rates.	Up to 1 year
Test performance at the time of initial cancer diagnosis by clinical stage	Diagnostic ability is assessed within each cancer stage and within each cancer type and stage combination by estimating the sensitivity and specificity with 95% confidence intervals. The width of these confidence intervals will vary by sample size and the sensitivity and specificity rates.	Up to 1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Marie Wood, MD

Phone Number: (720) 848-0300

Email: marie.wood@cuanschutz.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
40 Years

Accepts Healthy Volunteers:
1

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Marie Wood, MD, University of Colorado, Denver

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record