cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease

Active:	Yes
Cancer Type:	Bladder Cancer Breast Cancer Cervical Cancer Colon/Rectal Cancer Esophogeal Cancer Head and Neck Cancer Leukemia Lung Cancer Lymphoma Multiple Myeloma Ovarian Cancer Prostate Cancer Sarcoma Solid Tumor Stomach/ Gastric Cancer Thyroid Cancer	NCT ID:	NCT05366881
Trial Phases:		Protocol IDs:	Adela-EDMRD-001 (primary) NCI-2022-04272
Eligibility:	40 Years and older, Male and Female	Study Type:	Other
Study Sponsor:	Adela, Inc
NCI Full Details:	http://clinicaltrials.gov/show/NCT05366881

Summary

This is an observational case-control study to train and validate a genome-wide methylome
enrichment platform to detect multiple cancer types and to differentiate amongst cancer
types. The cancers included in this study are brain, breast, bladder, cervical,
colorectal, endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia,
lung, lymphoma, multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and
thyroid. These cancers were selected based on their prevalence and mortality to maximize
impact on clinical care.

Additionally, the ability of the whole-genome methylome enrichment platform to detect
minimal residual disease after completion of cancer treatment and to detect relapse prior
to clinical presentation will be evaluated in four cancer types (breast, colorectal,
lung, prostate). These cancers were selected based on the existing clinical landscape and
treatment availability.

Objectives

This is an observational case-control study that includes individuals with cancer and
individuals without known cancer. All participants will have clinical follow-up after
enrollment. A subset of individuals with cancer will also have longitudinal blood
sampling to evaluate the ability of the genome-wide methylome enrichment platform to
detect minimal residual disease. This includes individuals with Stage I-III breast,
colorectal, lung, or prostate cancer (Tier 1 Cancers).

At baseline, all participants will provide a blood sample and applicable clinical data.

Participants with a Tier 1 cancer will have clinical follow-up and blood draws after the
completion of first-line treatment, every 3 months for the first year after first-line
treatment, and every 6 months for an additional 2 years. All other cases will have
clinical follow-up once a year for 3 years after enrollment.

Control participants will have clinical follow-up every 6 months for up to 3 years from
enrollment to evaluate cancer status.

The blood test to be used in this study is a highly sensitive, epigenomic-based
genome-wide methylome enrichment platform. The assay includes bisulfite-free,
non-degradative genome-wide DNA methylation profiling from small quantities of cell-free
DNA (cfDNA). Libraries constructed from cfDNA are enriched for methylated CpGs and
preserve the native fragment length. This is followed by high throughput sequencing.

For all assays, samples from participants with cancer and participants without cancer
will be run together to reduce batch effects using methodology determined by the Sponsor.
Results from the liquid biopsy test will not be returned to clinicians or participants.

Treatment Sites in Georgia

Northeast Georgia Medical Center - Gainesville
NGMC-Gainesville
Wisteria Building Suite 420
200 South Enota
Gainesville, GA 30501
770-219-8822
www.nghs.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.