RecruitingNCT05334069
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
Sponsor
Alliance for Clinical Trials in Oncology
Enrollment
2,000 participants
Start Date
Aug 18, 2022
Study Type
OBSERVATIONAL
Conditions
Head and Neck CarcinomaMalignant Solid NeoplasmSarcomaThyroid Gland CarcinomaMelanomaGastroesophageal Junction AdenocarcinomaAcute Lymphoblastic LeukemiaAcute Myeloid LeukemiaAnn Arbor Stage I LymphomaAnn Arbor Stage II LymphomaAnn Arbor Stage III LymphomaAnn Arbor Stage IV LymphomaChronic Lymphocytic LeukemiaChronic Myeloid LeukemiaHematopoietic and Lymphoid Cell NeoplasmInvasive Breast CarcinomaKidney CarcinomaMalignant Hepatobiliary NeoplasmMuscle-Invasive Bladder CarcinomaRISS Stage I Plasma Cell MyelomaRISS Stage II Plasma Cell MyelomaRISS Stage III Plasma Cell MyelomaStage 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 v7
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.
Eligibility
Min Age: 40 YearsMax Age: 75 Years
Inclusion Criteria54
- 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
Interventions
OTHERQuestionnaire Administration
Complete questionnaire
PROCEDUREBiospecimen Collection
Undergo collection of tissue and blood samples
Locations(740)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05334069
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