Colvera for Detection of Disease Recurrence

Completed

Conditions studied: Colorectal Adenocarcinoma

In brief

To compare the sensitivity and specificity estimates of Colvera with that of a commercially available CEA test for detection of recurrent disease in CRC subjects who are undergoing surveillance for recurrence.

Key facts

Study ID

NCT03706235

Run by

Clinical Genomics Pathology

People needed

488

Starts

2018-02-01

Expected to finish

2020-04-29

Last updated by the study team

2020-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is 18 years or older, and capable and willing to provide informed consent.
• Subject has undergone curative treatment for primary CRC of stages II and III (AJCC).
• Subject has no clinical evidence of disease (NED) (after initial treatment)
• Subject has concluded course of initial treatment for primary CRC (i.e. end of surgery, chemotherapy and/or radiotherapy)
• Subject is willing/able to provide a blood sample

You may not qualify if…

• Subject has evidence of residual disease.
• Subject has other organ cancer at the time of recruitment.
• Subject has prior history of recurrent CRC.
• Subject has concurrent serious non-neoplastic illness that makes enrollment impractical or clinically inappropriate.
• Subject is receiving chemo- or radiotherapy at the time of blood collection, or between blood collection and radiological imaging.

Where it is running

• Torrance Memorial Physician Network — Redondo Beach, California, United States
• Bayhealth — Dover, Delaware, United States
• Rush University Medical Center — Chicago, Illinois, United States
• NorthShore Health System — Evanston, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Colon and Rectal Surgery Associates — Metairie, Louisiana, United States
• Providence Hospital-Ascension Health — Novi, Michigan, United States
• Virginia Piper Cancer Institute-Allina Health — Minneapolis, Minnesota, United States
• Essex Oncology — Belleville, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• University Hospitals — Cleveland, Ohio, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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