Collecting Blood Samples from Patients with and without Cancer to Evaluate Tests for Early Cancer Detection

Active:	Yes
Cancer Type:	Breast Cancer Head and Neck Cancer Hematopoietic Malignancies Kidney Cancer Leukemia Melanoma Sarcoma Solid Tumor Thyroid Cancer Unknown Primary	NCT ID:	NCT05334069
Trial Phases:		Protocol IDs:	A212102 (primary) A212102 A212102 NCI-2022-02477
Eligibility:	40 - 75 Years, Male and Female	Study Type:	Screening
Study Sponsor:	Alliance for Clinical Trials in Oncology
NCI Full Details:	http://clinicaltrials.gov/show/NCT05334069

Summary

This study collects blood and tissue samples from patients with cancer and without cancer to evaluate a test 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 researcher develop test for the early detection of cancers.

Objectives

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.
III. Evaluate test performance at the time of initial cancer diagnosis by type and stage separately for white non-Hispanic subjects and for minority subjects (subjects that are not white non-Hispanic).
Iv. Determine whether test performance is different for white non-Hispanic subjects compared to minorities.

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.

Treatment Sites in Georgia

Low Country Cancer Care Associates, PC
225 Candler Drive
Suite 201
Savannah, GA 31405
www.lcccsav.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.