Perioperative Cancer Cell Dissemination and Systemic Immune Suppression in Resectable Ductal Pancreatic Adenocarcinoma

NCT00495924 | Completed DMC

• 2 other identifiers: 3M070038G.0635.07
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether early recurrence after curative resection of ductal pancreatic adenocarcinoma can be explained by either dissemination of cancer cells during intraoperative tumour manipulation, post-operative systemic immune suppression, alteration of biological properties of circulating cancer cells or a combination of these.

Conditions

Pancreatic Neoplasms; Adenocarcinoma; Neoplasm Circulating Cells; Tumor Markers, Biological; Monitoring, Immunologic

Study Arms (1)

PD

Patients undergoing pancreaticoduodenectomy for pancreatic or peri-ampullary tumours.

Procedure: Pancreatic resection (PD)

Interventions

Pancreatic resection (PD) PROCEDURE

PD is a standard therapeutic surgical procedure. No additional interventions are performed.

PD

Eligibility Criteria

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

Study Population

Patients undergoing pancreaticoduodenectomy for pancreatic or peri-ampullary tumours.

You may qualify if:

• Suspected ductal pancreatic adenocarcinoma (pathological confirmation required after resection of tumour);
• Informed consent.

You may not qualify if:

• Any malignant tumour within 5 years prior to pancreatic resection.

Sponsors & Collaborators

• KU Leuven: lead
• Research Foundation Flanders: collaborator
• Agentschap voor Innovatie door Wetenschap en Technologie: collaborator

Study Sites (1)

Department of Abdominal Surgery, Catholic University Leuven

Leuven, Vlaams-Brabant, B-3060, Belgium

Location

Related Publications (2)

• Sergeant G, van Eijsden R, Roskams T, Van Duppen V, Topal B. Pancreatic cancer circulating tumour cells express a cell motility gene signature that predicts survival after surgery. BMC Cancer. 2012 Nov 16;12:527. doi: 10.1186/1471-2407-12-527.

  PMID: 23157946 DERIVED

• Sergeant G, Roskams T, van Pelt J, Houtmeyers F, Aerts R, Topal B. Perioperative cancer cell dissemination detected with a real-time RT-PCR assay for EpCAM is not associated with worse prognosis in pancreatic ductal adenocarcinoma. BMC Cancer. 2011 Jan 31;11:47. doi: 10.1186/1471-2407-11-47.

  PMID: 21281486 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, serum, blood

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenocarcinoma; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Baki Topal, MD, PhD

  Catholic University Leuven, Belgium

  STUDY DIRECTOR

• Gregory Sergeant, MD

  Catholic University Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 2, 2007
• First Posted: July 3, 2007
• Study Start: October 1, 2006
• Study Completion: October 1, 2008
• Last Updated: July 8, 2009

Record last verified: 2009-07

Locations

BE (1)