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

ConditionsAcute Lymphoblastic LeukemiaAcute Myeloid LeukemiaAnn Arbor Stage I LymphomaAnn Arbor Stage II LymphomaAnn Arbor Stage III LymphomaAnn Arbor Stage IV LymphomaChronic Lymphocytic LeukemiaChronic Myeloid LeukemiaGastroesophageal Junction AdenocarcinomaHead and Neck CarcinomaHematopoietic and Lymphoid Cell NeoplasmInvasive Breast CarcinomaKidney CarcinomaMalignant Hepatobiliary NeoplasmMalignant Solid NeoplasmMelanomaMuscle-Invasive Bladder CarcinomaRISS Stage I Plasma Cell MyelomaRISS Stage II Plasma Cell MyelomaRISS Stage III Plasma Cell MyelomaSarcomaStage I Bladder Cancer AJCC v6 and v7Stage I Breast Cancer AJCC v7Stage I Colorectal Cancer AJCC v6 and v7Stage I Esophageal Cancer AJCC V7Stage I Gastric Cancer AJCC V7Stage I Lung Cancer AJCC v7Stage I Ovarian Cancer AJCC v6 and v7Stage I Pancreatic Cancer AJCC v6 and v7Stage I Prostate Cancer AJCC v7Stage I Uterine Corpus Cancer AJCC v7Stage II Bladder Cancer AJCC v6 and v7Stage II Breast Cancer AJCC v6 and v7Stage II Colorectal Cancer AJCC v7Stage II Esophageal Cancer AJCC v7Stage II Gastric Cancer AJCC v7Stage II Lung Cancer AJCC v7Stage II Ovarian Cancer AJCC v6 and v7Stage II Pancreatic Cancer AJCC v6 and v7Stage II Prostate Cancer AJCC v7Stage II Uterine Corpus Cancer AJCC v7Stage III Bladder Cancer AJCC v6 and v7Stage III Breast Cancer AJCC v7Stage III Colorectal Cancer AJCC v7Stage III Esophageal Cancer AJCC v7Stage III Gastric Cancer AJCC v7Stage III Lung Cancer AJCC v7Stage III Ovarian Cancer AJCC v6 and v7Stage III Pancreatic Cancer AJCC v6 and v7Stage III Prostate Cancer AJCC v7Stage III Uterine Corpus Cancer AJCC v7Stage IV Bladder Cancer AJCC v7Stage IV Breast Cancer AJCC v6 and v7Stage IV Colorectal Cancer AJCC v7Stage IV Esophageal Cancer AJCC v7Stage IV Gastric Cancer AJCC v7Stage IV Lung Cancer AJCC v7Stage IV Ovarian Cancer AJCC v6 and v7Stage IV Pancreatic Cancer AJCC v6 and v7Stage IV Prostate Cancer AJCC v7Stage IV Uterine Corpus Cancer AJCC v7Thyroid Gland Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-75
SponsorAlliance for Clinical Trials in Oncology

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Patients with a cancer diagnosis and participants without cancer and without suspicion of cancer and with a high suspicion of cancer

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaire Administration

    Other intervention

    Complete questionnaire

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of tissue and blood samples

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: Screening (questionnaire, biospecimen collection)2 interventions

Trial outcomes

Primary outcomes

1

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

Diagnostic ability will be assessed across the entire cohort of 2000 subjects by estimating the sensitivity and specificity with 95% confidence intervals.

Time frame
Up to 1 year

Secondary outcomes

1

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

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.

Time frame
Up to 1 year
2

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

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.

Time frame
Up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alliance for Clinical Trials in Oncology

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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