Detection of Recurrent Colorectal Cancer by Assay of Novel Methylated DNA Markers in Plasma

Overview

About this study

The primary aims for this study:

  1. To select an optimal panel of novel MDMs for detection of recurrent or metastatic CRC and to assess MDM panel accuracy (sensitivity & specificity) for this application.

  2. To evaluate the ability of the plasma MDM assay to predict CRC recurrence when tested serially following curative resection of CRC metastases.

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

CONTROLS

Inclusion Criteria:

  • Consent obtained.
  • Age ≥ 40 years in NOMAD study.
  • Normal colonoscopy within past 5 years.

Exclusion Criteria:

  • Known history of non-cutaneous (except for melanoma) cancer within prior 5 years (or new cancer emerging within 3 years following blood draw).
  • Inability to provide blood sample.

CASES

Inclusion Criteria:

  • Newly diagnosed or recurrent stage II-IV CRC seen on imaging and confirmed by histology (Note: Bloods may be drawn in patients with suspected recurrence on imaging and prior to histologic report, but final inclusion will require histological confirmation of recurrent tumor) OR patients with stage II-IV CRC on current systemic treatment (chemo or radiation therapy) here for imaging studies as routine treatment monitoring, OR patients currently with no evidence of disease (NED) from resected stage II CRC, resected stage III CRC, or stage IV CRC with complete surgical resection, and confirmed by imaging and histology.
  • Consent obtained and able to provide blood samples.
  • Age ≥ 18 years.

Exclusion Criteria:

  • Inability to provide blood sample.
  • Known history of non-cutaneous (except for melanoma) cancer outside of the colon within prior 3 years.

RETROSPECTIVE STUDY ON ARCHIVAL TUMOR SPECIMENS

CASES

Inclusion Criteria:

 

  • Consent recorded in record.
  • Age ≥ 18 years.

Exclusion Criteria:

  • History of radiation to site of tumor being studied
  • Known familial cancer syndrome (e.g. Lynch syndrome, familial adenomatous polyposis)

CONTROLS

  • Buffy coat specimens as negative controls.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Hao Xie, M.D., Ph.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Hunter Miller

(507) 538-6747

Miller.Hunter@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Hao Xie, M.D., Ph.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions