Breast Cancer Clinical Trial

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

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.

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Full Description

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.

View Eligibility Criteria

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 is for people with:

Breast Cancer

Estimated Enrollment:

2000

Study ID:

NCT05334069

Recruitment Status:

Recruiting

Sponsor:

Alliance for Clinical Trials in Oncology

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Study is for people with:

Breast Cancer

Estimated Enrollment:

2000

Study ID:

NCT05334069

Recruitment Status:

Recruiting

Sponsor:


Alliance for Clinical Trials in Oncology

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