Paired Analysis of Sensitivity for Colorectal Cancer Using COLVERA : PASCAL

NCT03706248 | Completed

• 1 other identifier: CG0013
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Sensitivity, specificity, positive predictive value and negative predictive value

  Comparison of Colvera and CEA in recurrent and non-recurrent CRC

  1 year

Study Arms (2)

No recurrence

CT scan has confirmed that subjects are without recurrence. Blood can be drawn up to 4 weeks after scan. Effective Feb 28, 2019, this group is closed to accrual as it has reached the goal.

Other: Blood Draw

Recurrence

CT scan has confirmed that subjects are have recurrence of their colorectal cancer. Blood can be drawn prior to any treatment for the recurrent disease.

Other: Blood Draw

Interventions

Blood Draw OTHER

20 ml of blood will be drawn from subjects via venipuncture

No recurrence; Recurrence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This prospective study will enroll 50 subjects with radiologic confirmation of recurrence of colorectal cancer and 50 subjects without CRC recurrence (documented by CT scan). Eligible study subjects will include men and women (18 years or older) of any race and ethnicity who have completed treatment (no further adjuvant chemotherapy or surgery currently planned) for primary CRC of stages II and III (AJCC, \[2\]), and have been considered by the site clinical management team for at least 6 months to be in remission. . (Concurrent imaging is not required as part of the clinical determination of remission. Subjects who have had a recent (within 4 weeks) or prior CT scan for purposes of surveillance are eligible.)

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.

Sponsors & Collaborators

• Clinical Genomics Pathology: lead

Study Sites (6)

Torrance Memorial Physician Network

Redondo Beach, California, 90277, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Colon and Rectal Surgery Associates

Metairie, Louisiana, 70001, United States

Location

Providence Hospital-Ascension Health

Novi, Michigan, 48374, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

If there is leftover plasma, the plasma or the DNA extracted from the plasma may be stored at the sponsor for repeat assays.

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 15, 2018
• Study Start: July 28, 2018
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

US (6)