The Gene Expression Studies of the Role of Tumor Microenvironments in Tumor Progression
Withdrawn before enrolling
Conditions studied: Hypoxia, Lactic Acidosis
In brief
The purpose of this study is to analyze the gene expression patterns associated with various microenvironmental stresses in tumors to understand their roles in tumor progression and treatment responses. To achieve this goal, we will perform gene expression analysis of the tumor samples collected from an IRB-approved study (IRB #: 4516-05-2R2) International Phase III Study of Chemoradiotherapy versus Chemoradiotherapy Plus Hyperthermia for Locally Advanced Cervical Cancer directed by Dr. Mark Dewhirst. We will correlate the gene expression signatures of different microenvironmental stresses with the measured physiological parameters to understand their role in tumor progression, treatment response and clinical outcomes.
Key facts
- Study ID
- NCT00638040
- Run by
- Duke University
- People needed
- 0
- Starts
- 2009-09-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2014-07-11
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Invasive cervical carcinoma (small cell histology excluded)
- Age 18 or over
- FIGO stage IIb-IVa
- ECOG/WHO 0,1, or 2, or >/= 70% respectively
- WBC >/= 3,000, platelets >/= 100,000
- Hgb>12.0 g/dL or >7.5 mmol/L, with transfusion if needed
- Serum bilirubin </= 1.5 times ULN, transaminase </= 3 times ULN
- Calculated creatinine clearance > 60 ml/liter (Cockcroft)
- Para-aortic adenopathy absent or 1.5 cm in greatest dimension on CT/MRI
- No history of myocardial infarction in the last 6 months
- No symptomatic angina pectoris
- Any past history of coronary artery disease must require assessment and clearance by the PCP and/or cardiologist
- Negative pregnancy test in patients under 50
- Written informed consent
You may not qualify if…
- Patients who have undergone surgical resection of the primary tumor are not eligible (Limited surgical resection of pelvic nodes without TAH is acceptable)
- Patients with pacemakers or implanted defibrillators
- Patients with significant metallic foreign bodies (i.e. hip replacements, bone metallic rods, orthopedic plates, etc.)
- Prior radiotherapy or chemotherapy
Where it is running
- Duke Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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