Clinical Trials Directory

Trials / Recruiting

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

Status
Recruiting
Phase
—
Study type
Observational
Enrollment
2,000 (estimated)
Sponsor
Alliance for Clinical Trials in Oncology · Academic / Other
Sex
All
Age
40 Years – 75 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
OTHERQuestionnaire AdministrationComplete questionnaire
PROCEDUREBiospecimen CollectionUndergo collection of tissue and blood samples

Timeline

Start date
2022-08-18
Primary completion
2027-01-31
Completion
2027-02-28
First posted
2022-04-19
Last updated
2026-04-07

Locations

745 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT05334069. Inclusion in this directory is not an endorsement.