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

Breast Cancer Clinical Trial

— CAMPERR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05366881
• Other study ID #: Adela-EDMRD-001
• Status: Recruiting
• Start date: May 3, 2022
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Adela, Inc
• Contact: Brian Allen, MS
• Phone: 203-514-4155
• Email: brian.allen[@]adelabio.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. completion date: December 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Case Inclusion Criteria:

• 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

Case Exclusion Criteria:

• Currently receiving any treatment for cancer

• Currently taking any demethylating agents/DNA hypomethylating agents

• Simultaneously diagnosed with two or more invasive cancers

• Diagnosed with any invasive or non-invasive cancer in addition to the index cancer in the last 5 years

• Currently diagnosed with any chronic hematopoietic cancer (e.g. chronic CLL) in addition to the index cancer

• Currently diagnosed with any myelodysplastic syndromes and/or precursor hematologic conditions (e.g. MGUS) in addition to the index cancer

• Women who are known to be pregnant (self-reported)

Control Inclusion Criteria

• 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

Control Exclusion Criteria

• Currently receiving any treatment for cancer

• Currently taking any demethylating agents/DNA hypomethylating agents

• Women who are known to be pregnant (self-reported)

Related Conditions & MeSH terms

• Bladder Cancer
• Brain Cancer
• Brain Neoplasms
• Breast Cancer
• Cervical Cancer
• Colorectal Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Esophageal Cancer
• Head and Neck Cancer
• Hepatobiliary Cancer
• Kidney Neoplasms
• Leukemia
• Lung Cancer
• Lymphoma
• Multiple Myeloma
• Neoplasm, Residual
• Ovarian Cancer
• Pancreatic Cancer
• Prostate Cancer
• Renal Cancer
• Sarcoma
• Stomach Cancer
• Stomach Neoplasms
• Thyroid Cancer

Locations

Country	Name	City	State
United States	Elligo Health Research, Inc.	Austin	Texas
United States	Cleveland Clinic	Cleveland	Ohio
United States	Baptist Corbin	Corbin	Kentucky
United States	City of Hope	Duarte	California
United States	Baptist Hardin	Elizabethtown	Kentucky
United States	McLeod Health	Florence	South Carolina
United States	North Georgia Health System	Gainesville	Georgia
United States	Baptist Lexington	Lexington	Kentucky
United States	Baptist (BHMCC)	Memphis	Tennessee
United States	Miami Cancer Institute	Miami	Florida
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Baptist Floyd	New Albany	Indiana
United States	Baptist Paducah	Paducah	Kentucky
United States	Oregon Health Sciences University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Adela, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of cancer	Differentiation of cancer signals from cases and non-cancer signals from controls based on analysis of cfDNA using the genome-wide methylome enrichment platform	24 months
Secondary	Detection of specific cancer types	Differentiation of cancer signals from cases with a specific cancer type and non-cancer signals from controls based on analysis of cfDNA using the genome-wide methylome enrichment platform	24 months
Secondary	Tissue of origin	Identification of the correct tissue of origin (as determined by clinical diagnosis) for cancer cases based on analysis of cfDNA using the genome-wide methylome enrichment platform	18 months
Secondary	Clinical outcomes	Recurrence-free survival and overall survival among cancer cases	54 months