Molecular Assessment of Lymph Nodes in Patients With Resected (Stage I to IIIA) Non-small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Research of Molecular Markers for Diagnosis and/or Prognosis in Lymph Node Metastasis of Resected Non-small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213733
• Other study ID #: 3207
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: August 29, 2011
• Start date: June 2004
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

This is a prospective study of surgically resected samples and lymph nodes of lung cancer patients. For histopathologically positive lymph nodes from a complete resection, the investigators would like to analyse tumor tissue by allelotyping and comparing these results with those observed in the primary lung tumor to establish a cartography of molecular alteration in resected lung cancer. For non histopathologically positive lymph nodes, the investigators would like to research the presence (or not) of micrometastasis by allele-specific PCR (polymerase chain reaction).

Description:

Genetic: It is a prospective study during two years with three years for follow-up. No control group is recruited.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with resectable non-small cell lung cancer (stage I to IIIA), with a complete resection of the tumor and paired lymph nodes.

• Informed consent is required.

Exclusion Criteria:

• Another cancer

• Chemotherapy before surgical treatment

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
France	Laboratoire de Biochimie et de Biologie Moléculaire, Hôpital de Hautepierre	Strasbourg
France	Service d'Anatomie Pathologique, Hôpital de Hautepierre	Strasbourg
France	Service de Chirurgie Thoracique, Hôpital Civil	Strasbourg
France	Service de Pneumologie, Hôpital de Hautepierre	Strasbourg
France	Service de Pneumologie, Hôpital Lyautey	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France,