RecruitingPhase not listed

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

Blinded Reference Set for Multicancer Early Detection Blood Tests

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 75 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "OUTLINE: Participants complete a questionnaire at baseline."
  • "Participants undergo collection of blood samples at registration and at 12 months after registration."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects and stores blood and tissue samples to study tests that may find cancer early. It is for adults ages 40 to 75 who have cancer, may have certain cancers, or have no cancer or signs of cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be 40 to 75 years old.
  • You may join with no cancer or signs of cancer, or with a listed cancer: colon or rectum, bladder, head and neck, liver or bile ducts, lung, ovary, pancreas, stomach, food pipe, breast, thyroid, kidney, uterus lining, prostate, melanoma, sarcoma, lymphoma, leukemia, or multiple myeloma.
  • Cancer usually must be confirmed by a tissue test. If doctors strongly suspect ovarian, pancreatic, or kidney cancer, or melanoma, study leaders must review your records. A tissue or cell test must be planned within 28 days after the study blood draw.
  • You must have no other current or past cancer, including cancer that has not spread beyond where it started. Some non-melanoma skin cancers that have not spread are allowed.
  • If you have cancer, you must not have had treatment meant to treat that cancer.
  • You must not be pregnant, as far as you know, and must never have had an organ transplant.
  • You must be willing and medically able to give 60 mL of blood, about 4 tablespoons, for research.
  • You must be able to read and understand English or Spanish to complete study forms.

Who can't join

    Simplified for readability. The official criteria below are what the study team uses.

    Official eligibility criteria

    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

    Study sites (747)

    AK

    AR

    AZ

    CA

    CO

    CT

    DC

    FL

    GA

    IA

    ID

    IL

    IN

    KS

    KY

    LA

    MA

    MD

    ME

    MI

    MN

    MO

    MT

    NC

    ND

    NE

    NH

    • New Hampshire Oncology Hematology PA-Concord · Concord, NH 03301Site Public Contact · Study contact · 603-224-2556Gina M. DiVenuti · Principal investigatorMore trials in Concord
    • Solinsky Center for Cancer Care · Manchester, NH 03103Site Public Contact · Study contact · 800-339-6484Gina M. DiVenuti · Principal investigatorMore trials in Manchester

    NJ

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    NV

    NY

    OH

    OK

    OR

    PA

    RI

    SC

    SD

    TN

    TX

    VA

    WA

    WI

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    WY