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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	40 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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.

- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05334069
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Alliance for Clinical Trials in Oncology
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Marie Wood, MD
Principal Investigator Affiliation	University of Colorado, Denver
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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

Additional Details

PRIMARY OBJECTIVE:

I. To provide a blinded reference set of cancer versus (vs.#46;) 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.

Arms & Interventions

Arms

: 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.

Interventions

Other: - Questionnaire Administration

Complete questionnaire

Procedure: - Biospecimen Collection

Undergo collection of tissue and blood samples

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Anchorage 5879400, Alaska 5879092

Status

Recruiting

Address

Anchorage Associates in Radiation Medicine

Anchorage 5879400, Alaska 5879092, 98508

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