DNA Repair Genes and Outcomes in Patients With Stage III NSCLC

NCT00797238 | Unknown DMC

• 1 other identifier: 200709017R
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The studied materials contains surgically specimens of two groups of patiens with non-small cell lung cancer who have received two regimens of induction (neoadjuvant) chemotherapy before tumor resection. Pathological specimens of pre-chemotherapy and post-chemotherapy whatever retrievable will be collected. The protein ad RNA expression of DNA repair genes (ERCC1, ERCC2, XRCC1, XRCC3, BRCA1 and RRM1) as well as DNA polymorphisms of these genes will be studied, and will be correlate with the treatment response and outcome of the patients. The aims of this study include:

1. 1.To identify the expression status of the above DNA repair genes in Taiwanese NSCLC patients.
2. 2.To correlate the expression, as well as DNA polymorphism of each DNA repair gene in treatment response to two differenct chemotherapeutic regimens.
3. 3.To correlate the expression, as well as DNA polymorphism of each DNA repair gene in the outcome of stage III NSCLC patients.
4. 4.To explore whether platinum based chemotherapy will change the expression status of DNA repair gene and if indeed changed, whether this would influence the outcome of the patients

Conditions

Carcinoma, Non-Small-Cell Lung; Chemotherapy

Keywords

Gene Expression; Carcinoma, Non-Small-Cell Lung; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Change of the expression status of the DNA repair genes after chemotherapy in Taiwanese NSCLC patients

  before and after chemotherapy

Secondary Outcomes (1)

• Relationship between change of the expression status of the DNA repair genes after chemotherapy and clinical outcome

Study Arms (1)

NSCLC stage III

Taiwanese NSCLC patients with stage III

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Taiwanese NSCLC patients with stage III

You may qualify if:

• NSCLC patients with stage III in NTUH
• Recieved neoadjuvant chemotherapy and received operation

You may not qualify if:

• Patients who did not received chemotherapy or they did not receive operation.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 110, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

lung cancer tissue before and after treatment

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Chao-Chi Ho, Ph.D.

  Department of Internal Medicine and Emergency Medicine, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao-Chi Ho, Ph.D.

CONTACT

886-2-2356-2905; ccho1203@ntu.edu.tw

Chong-Jen Yu, Ph.D.

CONTACT

886-2-2356-2905; jefferycjyu@ntu.edu.tw

Study Design

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

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: November 25, 2008
• Study Start: September 1, 2007
• Study Completion: August 1, 2010
• Last Updated: July 15, 2010

Record last verified: 2010-07

Locations

TW (1)