The Gene Expression Studies of the Role of Tumor Microenvironments in Tumor Progression

NCT00638040 | Withdrawn DMC

• 3 other identifiers: Pro00006979R01CA1256189070-07
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoxia; Lactic Acidosis

Keywords

hypoxia; lactate; pH; tumor microenvironments; survival

Study Arms (1)

1

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The subjects will be de-identified and a system of patient identified will be used to correlate with the clinical data. The patients will be recruited as described in the original approved study. When patients with newly diagnosed cervix cancer are seen at Duke in the GYN Oncology Division or Radiation Oncology, appropriate patients will be offered protocol enrollment. Clinical faculty in both divisions also see new patients at satellite clinics elsewhere in North Carolina and Virginia, and eligible patients may also be enrolled from these encounters. We anticipate enrolling significant number of Spanish speaking women having in mind the increased growth of Latino population in the area.

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Medical Center

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Conditions

Hypoxia; Acidosis, Lactic

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jen-Tsan Chi, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 18, 2008
• Study Start: September 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 11, 2014

Record last verified: 2013-02

Locations

US (1)