Stool Testing for Pancreatic Cancer

NCT01104129 | Completed DMC

• 1 other identifier: AAAD8007
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if pancreatic cancer/pre-cancer can be detected in early stages through the molecular analysis of stool samples. Investigators hypothesize that analysis of stool samples using digital melt curve (DMC) analysis, can be used as a sensitive and specific method to detect the common genetic abnormalities present in pancreatic cancers and pre-cancerous lesions of the pancreas.

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer; Intraductal Papillary Mucinous Neoplasm (IPMN); Stool-based digital melt curve (DMC) assay; Surgical resection for pancreatic cancer; Hereditary Pancreatic Cancer Syndrome; Genetic mutations linked to pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Positive mutation rate in tumors/IPMN lesions vs. control

  The positive mutation rates in tumor or IPMN lesions and in matched controls will be assessed.

  30 days

Secondary Outcomes (1)

• Percentage of patients with genetic abnormalities correctly detected in stool samples

  30 days

Study Arms (2)

Control Group

Individual who has not had pancreatic cancer/IPMN; surgical resection for lesion of pancreas; history of colorectal, gastric cancer, esophageal, or head-and-neck cancer; administration of chemotherapy less than 1 week prior to enrollment; or an endoscopic procedure conducted less than 1 week prior to enrollment.

Diagnosis of Pancreatic Cancer/IPMN

Patients diagnosed with Pancreatic Cancer/Intraductal Papillary Mucinous Neoplasm who are scheduled for surgical resection.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with a diagnosis of pancreatic cancer/IPMN who are scheduled for surgical resection at Columbia University Medical Center's Pancreas Center will be accrued to this study.

You may qualify if:

• years of age and older.
• Tissue-confirmed or radiological evidence of either pancreatic adenocarcinoma or intrapapillary mucinous neoplasm(IPMN).
• Scheduled for surgical resection of the adenocarcinoma or IPMN.
• Able to give informed consent

You may not qualify if:

• History of colorectal, gastric cancer, esophageal, or head-and-neck cancer.
• Endoscopic procedure conducted less than 1 week prior to enrollment.
• Unwillingness or inability to sign informed consent.

Sponsors & Collaborators

• Columbia University: lead
• Mayo Clinic: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Tissue Collection: Fresh frozen resected tumor and IPMN tissue will be obtained whenever possible. All resected specimens, cancer and IPMN, will have histologic review to confirm the diagnosis. Ten slices of 10 microns each from each specimen will be prepared and sent to Mayo Clinic on dry ice. * Stool Collection: Prior to any surgery, stool will be collected from both study and control patients. Collection containers and mailing materials will be provided to subjects at time of their recruitment. Stool specimens will be mailed directly to Mayo Clinic within 48 hours of collection. Stool will be stored at 80 °C until assayed. * Stool DNA extraction: After stool is homogenized, crude stool DNA will be extracted and purified. * Digital melt curve mutation analysis: Target gene copies in captured stool DNA and tissue DNA will be quantified with real-time PCR. To target the mutations detected in tumor specimens, we will utilize PCR primers that scan for specific gene abnormalities.

MeSH Terms

Conditions

Pancreatic Neoplasms; Dyggve-Melchior-Clausen syndrome

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Wendy K Chung, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 15, 2010
• Study Start: July 9, 2009
• Primary Completion: November 29, 2016
• Study Completion: November 29, 2016
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)