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

Status: Recruiting
Location: See all (15) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: t
View:

• Newly diagnosed (within 90 days) with cancer or a recurrence of a cancer diagnosed \>5 years ago of one of the following subtypes: Invasive Brain, Breast, Bladder, Cervical, Colorectal, Endometrial, Esophageal, Gastric, Head and Neck, Hepatobiliary, Lung, Ovarian, Pancreatic, Prostate, Renal, Sarcoma, Thyroid; Leukemia, Lymphoma, Multiple Myeloma

• Able and willing to provide informed consent

• ≥40 years of age

• Not diagnosed with any cancer in the last 5 years (non-invasive cancer is allowed)

• Able and willing to provide informed consent

• ≥40 years of age

Locations
United States
California
City of Hope
RECRUITING
Duarte
Florida
Miami Cancer Institute
RECRUITING
Miami
Georgia
North Georgia Health System
RECRUITING
Gainesville
Indiana
Baptist Floyd
RECRUITING
New Albany
Kentucky
Baptist Corbin
RECRUITING
Corbin
Baptist Hardin
RECRUITING
Elizabethtown
Baptist Lexington
RECRUITING
Lexington
Baptist Paducah
WITHDRAWN
Paducah
Minnesota
Mayo Clinic
RECRUITING
Rochester
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Oregon
Oregon Health Sciences University
RECRUITING
Portland
South Carolina
McLeod Health
RECRUITING
Florence
Tennessee
Baptist (BHMCC)
RECRUITING
Memphis
Vanderbilt-Ingram Cancer Center
RECRUITING
Nashville
Texas
Elligo Health Research, Inc.
RECRUITING
Austin
Contact Information
Primary
Brian Allen, MS
brian.allen@adelabio.com
203-514-4155
Backup
Michelle Anderson
michelle.anderson@adelabio.com
475-766-8183
Time Frame
Start Date: 2022-05-03
Estimated Completion Date: 2026-12
Participants
Target number of participants: 7000
Treatments
Cases
Cases will include participants with newly diagnosed, treatment-naive cancer at the time of enrollment.
Controls
Controls will include participants without known cancer at the time of enrollment.
Sponsors
Leads: Adela, Inc

This content was sourced from clinicaltrials.gov

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