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

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05334069

Collaborator

National Cancer Institute (NCI) (NIH)

2,000

Enrollment

32.1

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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

Detailed Description

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.
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

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Blinded Reference Set for Multicancer Early Detection Blood Tests

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jan 31, 2025

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

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 months after registration.	Other: Questionnaire Administration Complete questionnaire Procedure: Biospecimen Collection Undergo collection of tissue and blood samples

Arm

Intervention/Treatment

Screening (questionnaire, biospecimen collection)

Other: Questionnaire Administration

Complete questionnaire

Procedure: Biospecimen Collection

Undergo collection of tissue and blood samples

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Test performance at the time of initial cancer diagnosis by tumor type [Up to 1 year]
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.
Test performance at the time of initial cancer diagnosis by clinical stage [Up to 1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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