Paired Analysis of Sensitivity for Colorectal Cancer Using COLVERA : PASCAL

Colorectal Cancer Clinical Trial

— PASCAL  

Official title:

Evaluation of the Performance and Sensitivity of the Clinical Genomics Colvera Test in Predicting Recurrence of Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03706248
• Other study ID #: CG0013
• Status: Completed
• Start date: July 28, 2018
• Est. completion date: July 15, 2019

Study information

• Verified date: February 2020
• Source: Clinical Genomics Pathology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

The study will be carried out as a single cohort, observational, prospective study to compare sensitivity of Colvera to detect recurrent colorectal cancer confirmed by radiology imaging (CT) with CEA sensitivity in paired testing. Blood is collected for assay of methylated BCAT1 and IKZF1 DNA and CEA, from subjects who have undergone curative treatment for primary CRC of stages II and III (AJCC) and who are in remission (No evidence of disease). Subjects will have recently (within 4 weeks of blood collection) had follow-up radiological imaging as part of their surveillance program for recurrence. Participation is for one visit only as part of each subject's surveillance-monitoring schedule. Two PAXgene blood tubes (minimum 10 mL, maximum 20 mL) will be collected. Any evidence of methylated BCAT1 and/or IKZF1 DNA in blood represents a Colvera "positive" result. CEA levels of 5ug/L or higher will represent a "positive" result. Sensitivity and specificity of the Colvera and CEA test will be estimated and compared in a paired fashion in each case where recurrence status has been investigated and determined by the site clinical management team. Blood testing shall be performed and analyzed by qualified staff blinded to clinical status. This is a cross-sectional observational non-significant risk study, and test results will not be used for clinical management, i.e. there will be no interventions in subjects consenting to participate in this Research Study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is 18 years or older, and capable and willing to provide informed consent.

2. Subject has undergone curative treatment for primary CRC of stages II and III (AJCC).

3. 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.)

4. 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.

5. Subject is willing to provide a blood sample. (2 PAXgene tubes)

6. 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

Exclusion Criteria:

1. Subject has other cancer at the time of recruitment.

2. Subject has prior history of recurrent CRC.

3. Subject has a diagnosis of End Stage Renal Disease (ESRD), with or without current dialysis treatment.

4. Subject's life expectancy is less than one year based on performance status and clinical signs and symptoms.

5. Subject is receiving chemo- or radiotherapy at the time of blood collection, or between radiological imaging and blood collection.

6. 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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Blood Draw
20 ml of blood will be drawn from subjects via venipuncture

Locations

Country	Name	City	State
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	Torrance Memorial Physician Network	Redondo Beach	California
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Genomics Pathology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, specificity, positive predictive value and negative predictive value	Comparison of Colvera and CEA in recurrent and non-recurrent CRC	1 year