Detection of Esophageal Cancer by Assay of Novel Methylated DNA Markers in Plasma

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 18-004438
    Sponsor Protocol Number: 18-004438

About this study

The purpose of the study is to see if the plasma assay of MDMs using optimized markers and analytically sensitive assays will detect early-stage esophageal cancer at high specificity.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

Cases:

  • Consent for study
  • >3 mL single spun plasma available
  • Esophageal adenocarcinoma or Esophageal squamous cell carcinoma diagnosed by biopsy of the primary lesion, or by biopsy of lymph node or distant metastasis

Controls:

  • Consent for study
  • >3 mL single spun plasma available

 

Exclusion Criteria:

Cases:

  • Known primary cancer outside of the esophagus, detected within 5 years prior to collection, and within 3 years after, excluding basal cell or squamous skin cancers.
  • Prior chemotherapy class drugs or radiation for the primary esophageal cancer
  • Biopsy/endoscopic/surgical treatment with intent to remove or de-bulk the primary lesion prior to stool and plasma collection
  • Age <18

Controls:

  • History of esophageal cancer (squamous or adenocarcinoma)
  • Known primary cancer outside of the esophagus, detected within 5 years prior to collection, and within 3 years after, excluding skin cancers
  • Age <18
  • Diagnosis of Familial cancer syndromes such as HPNCC and FAP

Stool-specific, for both controls and cases:

  • Bowel prep <7 days prior to stool collection
  • Removal of >50% of colon or presence of ileostomy
  • Enteral feeds or TPN
  • Diagnosis of inflammatory bowel disease.
  • Pre-cancerous polyps or cancer found at baseline study colonoscopy
  • Diagnosis of Familial cancer syndromes such as HPNCC and FAP
  • Enteric barium studies within the prior 7 days before stool collection

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

John Kisiel, M.D.

Open for enrollment

Contact information:

Kari Lowrie

(507)266-3778

Lowrie.Kari@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20439038

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