Clinical trial NCT05366881: cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Official title: cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Keywords: Multi-cancer early detection
Liquid Biopsy
Methylome
Cancer screening
cell-free DNA
Lead sponsor: Adela, Inc
Sponsor class: INDUSTRY
First posted: 2022-05-09
Enrollment: 7000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll individuals with newly diagnosed cancer as cancer cases and individuals without known cancer as controls. Participants will be enrolled from sites across the United States.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Detection of cancer
timeFrame: 24 months
Secondary outcomes:
measure: Detection of specific cancer types
timeFrame: 24 months
measure: Tissue of origin
timeFrame: 18 months
measure: Clinical outcomes
timeFrame: 54 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Miami
country: United States
facility: Miami Cancer Institute
state: Florida
city: Gainesville
country: United States
facility: North Georgia Health System
state: Georgia
city: New Albany
country: United States
facility: Baptist Floyd
state: Indiana
city: Corbin
country: United States
facility: Baptist Corbin
state: Kentucky
city: Elizabethtown
country: United States
facility: Baptist Hardin
state: Kentucky
city: Lexington
country: United States
facility: Baptist Lexington
state: Kentucky
city: Paducah
country: United States
facility: Baptist Paducah
state: Kentucky
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Florence
country: United States
facility: McLeod Health
state: South Carolina
city: Memphis
country: United States
facility: Baptist (BHMCC)
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Austin
country: United States
facility: Elligo Health Research, Inc.
state: Texas
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Brian Rini, MD
role: PRINCIPAL_INVESTIGATOR
References: