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Trial record 1 of 1 for:    NCT05366881
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cfMeDIP-seq Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease (CAMPERR)

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ClinicalTrials.gov Identifier: NCT05366881
Recruitment Status : Recruiting
First Posted : May 9, 2022
Last Update Posted : June 21, 2022
Sponsor:
Information provided by (Responsible Party):
Adela, Inc.

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
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.

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2026


Group/Cohort
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.



Primary Outcome Measures :
  1. Detection of cancer [ Time Frame: 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 :
  1. Detection of specific cancer types [ Time Frame: 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

  2. Tissue of origin [ Time Frame: 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

  3. Clinical outcomes [ Time Frame: 54 months ]
    Recurrence-free survival and overall survival among cancer cases


Biospecimen Retention:   Samples With DNA
Plasma and extracted cell-free DNA


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05366881


Contacts
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Contact: Brian Allen, MS 203-514-4155 brian.allen@adelabio.com
Contact: Michelle Anderson 475-766-8183 michelle.anderson@adelabio.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Xiao-Yu Xia    626-218-0630    xxia@coh.org   
Principal Investigator: Gregory Idos, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Mofetoluwa Oluwasanmi    216-444-0843    oluwasm@ccf.org   
Principal Investigator: Peter Mazzone, MD, MPH         
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37203
Contact: Anna Dumont       anna.dumont@vumc.org   
Principal Investigator: Brian Rini, MD         
Sponsors and Collaborators
Adela, Inc.
Investigators
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Principal Investigator: Brian Rini, MD Vanderbilt-Ingram Cancer Center
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Responsible Party: Adela, Inc.
ClinicalTrials.gov Identifier: NCT05366881    
Other Study ID Numbers: Adela-EDMRD-001
First Posted: May 9, 2022    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adela, Inc.:
Multi-cancer early detection
Liquid Biopsy
Methylome
Cancer screening
cell-free DNA
Additional relevant MeSH terms:
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Multiple Myeloma
Endometrial Neoplasms
Neoplasm, Residual
Brain Neoplasms
Kidney Neoplasms
Stomach Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Genital Neoplasms, Female
Uterine Neoplasms
Uterine Diseases
Urologic Neoplasms
Urologic Diseases