Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT00075569
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed grade III cervical intraepithelial neoplasia (CIN III) with colposcopically visible cervical lesions
* No positive endocervical curettage or inadequate colposcopy at the time of initial cervical biopsy
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* WBC at least 3,500/mm\^3
* Lymphocyte count at least 500/mm\^3
* Platelet count at least 150,000/mm\^3
* Hemoglobin at least 10 g/dL
* No significant hematologic disease that is uncontrolled with standard therapy
Hepatic
* Bilirubin no greater than 2 mg/dL
* Liver enzymes no greater than 2.5 times normal
* No significant hepatic disease that is uncontrolled with standard therapy
Renal
* Creatinine no greater than 2 mg/dL
* No significant renal disease that is uncontrolled with standard therapy
Cardiovascular
* No significant cardiovascular disease that is uncontrolled with standard therapy
Pulmonary
* No significant respiratory disease that is uncontrolled with standard therapy
* No history of asthma
Immunologic
* HIV negative
* No clinical evidence of immunosuppression
* No autoimmune disease
* No history of allergic reactions attributed to compounds of similar chemical or biological activity as those used in this study
* No history of a positive purified protein derivative (PPD) or Tine test
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Good health based upon the results of a medical history, physical examination, vital signs, and laboratory profile
* No uncontrolled chronic disease
* Chronic disease requiring medication is allowed provided the patient is not taking immunosuppressive drugs
* No significant endocrine (e.g., thyroid or diabetes), neurologic, gastrointestinal, or dermatologic disease that is uncontrolled with standard therapy
* No other underlying or unstable disease that would be exacerbated by the study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior BCG vaccination
* No other concurrent vaccine therapy
Chemotherapy
* No concurrent chemotherapy
Endocrine therapy
* More than 30 days since prior oral or parenteral glucocorticoid steroid
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* More than 30 days since prior participation in another investigational study
* No concurrent cytotoxic therapy
* No other concurrent investigational agents
* No other concurrent investigational or commercial agents or therapies intended to treat CIN
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00075569
Study Brief:
Protocol Section:
NCT00075569