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Status unknownNCT00797238Updated Jul 15, 2010

DNA Repair Genes and Outcomes in Patients With Stage III NSCLC

An observational study in Carcinoma, Non-Small-Cell Lung and Chemotherapy, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2010-07-15.

Sponsored by National Taiwan University Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2010), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 90 Years
Sex
All
01

Study 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. To identify the expression status of the above DNA repair genes in Taiwanese NSCLC patients.
  2. To correlate the expression, as well as DNA polymorphism of each DNA repair gene in treatment response to two differenct chemotherapeutic regimens.
  3. To correlate the expression, as well as DNA polymorphism of each DNA repair gene in the outcome of stage III NSCLC patients.
  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
Read the detailed description

Patients with clinical stage IIIA N2 non-small cell lung cancer (NSCLC) have a 5-year survival rate of 10% to 15%, much worse than those of earlier stages of disease. The use of pre-operative (neo-adjuvant) chemotherapy has been shown to be beneficial in several studies.1 However, the precise chemotherapeutic regimen for neoadjuvant therapy remains an open question.

The treatment response and toxicity of chemotherapy vary widely among and within individuals, and races. Recently, molecular predictive markers may help to identify who may benefit from individual therapy. Many evidence shows that the level of ERCC1 (an excision nuclease within the nucleotide excision repair pathway) is important for the repair of platinum-DNA adducts and the response to platinum-based chemotherapy.2-5 Not only by measuring protein and mRNA expression, studies addressed on the polymorphism of ERCC1(118 C/T and C8092A) had demonstrated impact on survival of chemotherapy-treated NSCLC patients6,7. XPD/ERCC2 (xeroderma pigmentosum group D/excision repair cross-complementing group 2) 8, XRCC1 (X-ray repair cross-complementing group 1) and XRCC3 (X-ray repair cross-complementing group 3) are another three proteins involving NER, serving as prognostic factor of survival.9 BRCA1 is a protein participating in recombinant repair (RR) and is stronge predictive marker of chemotherapy response. BRCA1 functions as a differential modulator of survival with cisplatin and antimicrotubule drugs (paclitaxel, docetaxel and vinorelbine). Low level of BRCA1 enhance cisplatin activity but lead to resistance to paclitaxel, docetaxel and vinorelbine, whereas the opposite phenomenon is observed in the presence of normal or high levels of BRCA1. In contract, BRCA1 levels do not influence the effect of gemcitabine10. On the contrary, RRM1 (ribonucleotid reductase subunit M1) is involved in gemcitabine metabolism and DNA repair after chemotherapy damage, and increased RRM1 mRNA expression has been related to gemcitabine resistance in NSCLC11. All these DNA repair genes participate the pathogenesis, mechanism of chemotherapeutic resistance and outcome of lung cancer patients.

Previously, a joint study done by NTUH and VGH Taipei used gemcitabine and cisplatin as induction chemotherapy to treat 52 patient with stage III NSCLC, 36 were operable and 18 were completely resected.12 From 2004 till now, a prospective study has been performed in NTUH using docetaxel and cisplatin as neoadjuvant regimen to treat patients with stage IIIA (N2) non-small cell lung cancer. Up to now, more than 40 patients were enrolled, all of them have received tumor sampling before chemotherapy and more 90% received operation with their tumor resected. The tissue specimens are valuable as all these patients had received protocolized treatment, with filed detailed clinical information collected systematically. All the peroperative biopsied and operatively resected tumor tissues are available in paffin-embedded block, some in frozen tissue stock, we plan to study the DNA polymorphism, protein and RNA expression of the above-mentioned DNA repair genes in these two series of patients.

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung
  • Chemotherapy

Keywords

  • Gene Expression
  • Carcinoma, Non-Small-Cell Lung
  • Chemotherapy
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 100 is below the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Taiwanese NSCLC patients with stage III

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients who did not received chemotherapy or they did not receive operation.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • NSCLC stage III

    Taiwanese NSCLC patients with stage III

06

What researchers measure

Primary outcomes

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

    Time frame: before and after chemotherapy

Secondary outcomes

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

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, 110, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00797238
Lead sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan
First posted
Nov 25, 2008
Start date
Sep 2007
Completion
Aug 2010 (estimated)
Last update
Jul 15, 2010

Study contacts

Chao-Chi Ho, Ph.D.
Contact
ccho1203@ntu.edu.tw
886-2-2356-2905
Chong-Jen Yu, Ph.D.
Contact
jefferycjyu@ntu.edu.tw
886-2-2356-2905
Chao-Chi Ho, Ph.D.
principal investigator · Department of Internal Medicine and Emergency Medicine, National Taiwan University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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