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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 years
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a method that looks at chemical marks on DNA to find and tell apart many types of cancer. It includes adults age 40 or older with and without cancer. For lung cancer, it also tests whether the method can find small amounts of cancer left after treatment or cancer that returns before signs appear.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Everyone: Age 40 or older and able and willing to give informed consent (agree to join after learning about the study).
  • Cancer group: Cancer diagnosed within 120 days, or a return of cancer first diagnosed more than 5 years ago.
  • Cancer group: Eligible cancers include invasive cancers of the brain, breast, bladder, cervix, colon or rectum, uterus lining, esophagus (food pipe), stomach, head and neck, liver or bile system, lung, ovary, pancreas, prostate, kidney, or thyroid; sarcoma; leukemia; lymphoma; or multiple myeloma. Invasive means cancer has grown into nearby tissue.
  • Comparison group: No cancer diagnosis in the last 5 years, except non-invasive cancer (cancer that has not grown into nearby tissue).

Who can't join

  • Everyone: Currently getting cancer treatment.
  • Everyone: Currently taking drugs that remove or reduce chemical marks called methyl groups on DNA.
  • Everyone: Women who report that they are pregnant.
  • Cancer group: Two or more invasive cancers diagnosed at the same time.
  • Cancer group: Any other invasive or non-invasive cancer diagnosed in the last 5 years.
  • Cancer group: Another ongoing blood cancer, such as chronic lymphocytic leukemia (CLL).
  • Cancer group: Another bone marrow disorder called myelodysplastic syndrome, or a blood condition that may come before cancer, such as MGUS.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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)

Study sites (17)

CA

FL

GA

IN

KY

MN

OH

OR

SC

TN

TX