Paired Analysis of Sensitivity for Colorectal Cancer Using COLVERA : PASCAL

Completed

Conditions studied: Colorectal Cancer

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 subjects with colorectal cancer that have documented recurrence or no evidence of recurrence by CT.

Key facts

Study ID

NCT03706248

Run by

Clinical Genomics Pathology

People needed

65

Starts

2018-07-28

Expected to finish

2019-07-15

Last updated by the study team

2020-02-13

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 was determined to be in remission at the conclusion of primary therapy and has been in clinical surveillance for at least 6 months. (No imaging is required for the determination of remission. Last treatment was at least 6 months earlier. No requirement to complete all of the initial adjuvant treatment plan.)
• Subject has had a surveillance CT scan within the past 4 weeks and either has recurrent CRC or does not have recurrent CRC based on that CT scan result.
• Subject is willing to provide a blood sample. (2 PAXgene tubes)
• Definition of recurrence is evidence of local tumor recurrence or metastasis by CT scan of chest, abdomen and pelvis or other modalities that confirm recurrent CRC

You may not qualify if…

• Subject has other cancer at the time of recruitment.
• Subject has prior history of recurrent CRC.
• Subject has a diagnosis of End Stage Renal Disease (ESRD), with or without current dialysis treatment.
• Subject's life expectancy is less than one year based on performance status and clinical signs and symptoms.
• Subject is receiving chemo- or radiotherapy at the time of blood collection, or between radiological imaging and blood collection.
• Results of the recent surveillance CT of the chest, abdomen and pelvis are inconclusive regarding recurrence of CRC, and further work up (other imaging and/or biopsy) is not required at this time.

Where it is running

• Torrance Memorial Physician Network — Redondo Beach, California, United States
• University of South Florida — Tampa, Florida, United States
• Rush University Medical Center — Chicago, 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

Full record on ClinicalTrials.gov

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