Detection of Recurrent Colorectal Cancer by Assay of Novel Methylated DNA Markers in Plasma
Overview
Tab Title Description
Study type
ObservationalDescribes 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.
Study IDs
Site IRB
- Rochester, Minnesota: 17-008184
- Jacksonville, Florida: 17-008184
Sponsor Protocol Number: 17-008184
About this study
The primary aims for this study:
-
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.
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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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Hao Xie, M.D., Ph.D. |
Closed for enrollment |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Hao Xie, M.D., Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available