Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT05334069
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2022-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Study Overview
Official Title:
Blinded Reference Set for Multicancer Early Detection Blood Tests
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2022-02477 | REGISTRY | NCI Clinical Trial Reporting Program | View | |
| UG1CA189823 | NIH | None | https://reporter.nih.gov/quic… | View |