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NCT Number: NCT05366881

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

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 lung cancer. This cancer was selected based on the existing clinical landscape and treatment availability.

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Key information

Conditions

Brain Cancer Adnexal Diseases Bladder Cancer Blood Protein Disorders Brain Diseases Brain Neoplasms Breast Cancer Breast Diseases Breast Neoplasms Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Neoplasms Cervical Cancer Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Cancer Head and Neck Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hepatobiliary Cancer Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Leukemia Lung Cancer Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Male Urogenital Diseases Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Plasma Cell Nervous System Diseases Nervous System Neoplasms Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Paraproteinemias Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Renal Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin and Connective Tissue Diseases Stomach Cancer Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Thyroid Cancer Thyroid Diseases Thyroid Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

City of Hope, Duarte, California, United States

Loading trial locations.

About this study

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 lung 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 may 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Case Inclusion Criteria:

  • Newly diagnosed (within 120 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)

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Brian Allen, MS

CONTACT

[email protected]

203-514-4155

Michelle Anderson

CONTACT

[email protected]

475-766-8183

Sponsors and collaborators

Lead sponsor

Adela, Inc

Industry

Registry information

Official study title

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

Acronym: CAMPERR

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
May 9, 2022
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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