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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00213733
First received: September 13, 2005
Last updated: August 29, 2011
Last verified: August 2011
  Purpose

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).


Condition
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Research of Molecular Markers for Diagnosis and/or Prognosis in Lymph Node Metastasis of Resected Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Estimated Enrollment: 150
Study Start Date: June 2004
Study Completion Date: August 2011
Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213733

Locations
France
Laboratoire de Biochimie et de Biologie Moléculaire, Hôpital de Hautepierre
Strasbourg, France, 67098
Service d'Anatomie Pathologique, Hôpital de Hautepierre
Strasbourg, France, 67098
Service de Chirurgie Thoracique, Hôpital Civil
Strasbourg, France, 67091
Service de Pneumologie, Hôpital de Hautepierre
Strasbourg, France, 67098
Service de Pneumologie, Hôpital Lyautey
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Michèle BEAU-FALLER, MD Laboratoire de Biochimie et de Biologie Moléculaire, Hôpital de Hautepierre
  More Information

No publications provided

Responsible Party: Emmanuel LAVOUE, Directeur Adjoint de la DRCI, University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00213733     History of Changes
Other Study ID Numbers: 3207
Study First Received: September 13, 2005
Last Updated: August 29, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
Lung cancer patients
non-small cell lung cancer
molecular marker
lymph node completed resected
Lung cancer samples and paired lymph node resected

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014