CAMPERR: cfMeDIP-seq Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease

Sponsor

Adela, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05366881

Collaborator

(none)

5,280

Enrollment

Locations

Anticipated Duration (Months)

1760

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Brain Cancer Breast Cancer Bladder Cancer Cervical Cancer Colorectal Cancer Endometrial Cancer Esophageal Cancer Stomach Cancer Head and Neck Cancer Hepatobiliary Cancer Leukemia Lung Cancer Lymphoma Multiple Myeloma Ovarian Cancer Pancreatic Cancer Prostate Cancer Renal Cancer Sarcoma Thyroid Cancer

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

5280 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

cfMeDIP-seq Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse

Actual Study Start Date :

May 3, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Detection of cancer [24 months]
Differentiation of cancer signals from cases and non-cancer signals from controls based on analysis of cfDNA using the genome-wide methylome enrichment platform

Secondary Outcome Measures

Detection of specific cancer types [24 months]
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
Tissue of origin [18 months]
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
Clinical outcomes [54 months]
Recurrence-free survival and overall survival among cancer cases

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope	Duarte	California	United States	91010
2	Cleveland Clinic	Cleveland	Ohio	United States	44195
3	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37203