History of Changes for Study: NCT05334069

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

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Study Record Versions

Version	Submitted Date	Changes
1	April 12, 2022	None (earliest Version on record)
2	March 16, 2023	Recruitment Status, Study Status and Contacts/Locations
3	August 30, 2023	Contacts/Locations and Study Status
4	October 30, 2023	Contacts/Locations and Study Status
5	February 19, 2024	Contacts/Locations and Study Status
6	April 8, 2024	Contacts/Locations and Study Status

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Side-by-Side

Study Identification


Unique Protocol ID:	A212102
Brief Title:	Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Official Title:	Blinded Reference Set for Multicancer Early Detection Blood Tests
Secondary IDs:	NCI-2022-02477 [Registry Identifier: NCI Clinical Trial Reporting Program] UG1CA189823 [U.S. NIH Grant/Contract]

Study Status


Record Verification:	April 2022
Overall Status:	Not yet recruiting
Study Start:	June 2022
Primary Completion:	January 31, 2025 [Anticipated]
Study Completion:	February 2025 [Anticipated]

First Submitted:	April 12, 2022
First Submitted that Met QC Criteria:	April 12, 2022
First Posted:	April 19, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	April 12, 2022
Last Update Posted:	April 19, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	Alliance for Clinical Trials in Oncology
Responsible Party:	Sponsor
Collaborators:	National Cancer Institute (NCI)

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

Brief 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.

Detailed 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.

Conditions

Conditions:

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

Keywords:

Study Design


Study Type:	Observational
Observational Study Model:	Case-Control
Time Perspective:	Prospective
Biospecimen Retention:	Samples With DNA
Biospecimen Description:	Blood, tissue
Enrollment:	2000 [Anticipated]
Number of Groups/Cohorts	1

Groups and Interventions

Groups/Cohorts	Interventions
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.	Questionnaire Administration Complete questionnaire Procedure: Biospecimen Collection Undergo collection of tissue and blood samples

Outcome Measures


Primary Outcome Measures:
1.	Provision of blinded reference set of cancer versus non-cancer blood samples [ Time Frame: Up to 1 year ] Diagnostic ability will be assessed across the entire cohort of 2000 subjects by estimating the sensitivity and specificity with 95% confidence intervals.
Secondary Outcome Measures:
1.	Test performance at the time of initial cancer diagnosis by tumor type [ Time Frame: Up to 1 year ] 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.
2.	Test performance at the time of initial cancer diagnosis by clinical stage [ Time Frame: Up to 1 year ] 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.

Eligibility


Study Population:	Patients with a cancer diagnosis and participants without cancer and without suspicion of cancer and with a high suspicion of cancer
Sampling Method:	Non-Probability Sample
Minimum Age:	40 Years
Maximum Age:	75 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
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

Contacts/Locations


Central Contact Person:	Marie Wood, MD Telephone: 802-655-5415 Email: marie.wood@uvmhealth.org
Study Officials:	Marie Wood, MD Study Chair University of Vermont Medical Center
Locations:

IPDSharing


Plan to Share IPD:

References


Citations:
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