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NCT Number: NCT05334069

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Adenocarcinoma Ann Arbor Stage I Lymphoma Ann Arbor Stage II Lymphoma Ann Arbor Stage III Lymphoma Ann Arbor Stage IV Lymphoma Bone Marrow Diseases Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Renal Cell Chronic Disease Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastroesophageal Junction Adenocarcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Head and Neck Carcinoma Head and Neck Neoplasms Hematologic Diseases Hematologic Neoplasms Hematopoietic and Lymphoid Cell Neoplasm Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Intestinal Neoplasms Invasive Breast Carcinoma Kidney Carcinoma Kidney Diseases Kidney Neoplasms Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoproliferative Disorders Male Urogenital Diseases Malignant Hepatobiliary Neoplasm Malignant Solid Neoplasm Melanoma Muscle-Invasive Bladder Carcinoma Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Prostatic Diseases Prostatic Neoplasms RISS Stage I Plasma Cell Myeloma RISS Stage II Plasma Cell Myeloma RISS Stage III Plasma Cell Myeloma Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases 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 Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Thyroid Diseases Thyroid Gland Carcinoma Thyroid Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

Other

Complete questionnaire

Biospecimen Collection

Procedure

Undergo collection of tissue and blood samples

Primary outcomes

  1. Provision of blinded reference set of cancer versus non-cancer blood samples

    Time frame: 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 outcomes

  1. Test performance at the time of initial cancer diagnosis by tumor type

    Time frame: 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.

  2. Test performance at the time of initial cancer diagnosis by clinical stage

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marie Wood, MD

CONTACT

[email protected]

(720) 848-0300

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Blinded Reference Set for Multicancer Early Detection Blood Tests

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 19, 2022
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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