Project for molecular profiling for lung cancer( genetic mutation testing)
- Conditions
- Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Registration Number
- CTRI/2022/12/048326
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. The availability of sufficient archival tumor tissue specimen
2. Age >= 21 years
3. WHO performance status ï?£ 2
4. Life expectancy of >= 12 weeks
5. Patients should have adequate organ function for potential consideration into clinical trials (routine blood tests are valid within 14 days before enrollment):
o Adequate bone marrow function as shown by: ANC >= 1.0 x 109/L, Platelets >= 75 x 109/L, Hb >= 7.5 g/dL
o Alanine aminotransferase (ALT) and aspirate aminotransferase (AST) normal range (or <=3.0 x ULN if liver metastases are present)
6. Willing to provide signed informed consent
7. Patients whom do not fulfill the above criteria may be discussed on a case-by-case basis with the study team, for potential enrolment
1. No more than 3 lines of cytotoxic chemotherapy at the time of enrolment
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To evaluate the molecular epidemiology of NSCLC in Asia via comprehensive, prospective molecular profiling of lung cancer specimens â?? in both resected tumours and small biopsy specimens. <br/ ><br>2.To develop a predictive model based on clinical-pathologic characteristics in Asian NSCLC patients. <br/ ><br>Timepoint: 1.Baseline <br/ ><br>2. 2 years <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.To ascertain the extent of access to novel/targeted therapies and immunotherapy for patients found to have an actionable biomarker. <br/ ><br>2.To determine outcomes of patients (PFS and OS) in molecularly defined subgroups of NSCLC. <br/ ><br>Timepoint: 1. 2 years <br/ ><br>2. Till disease Progression and / or till death