Cervical Adenocarcinoma Clinical Trial
Official title:
Lymphatic Mapping and Sentinel Node Identification in Patients With Stage1B1 Cervical Carcinoma
Verified date | June 2015 |
Source | Gynecologic Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This clinical trial is studying how well lymph node mapping and sentinel lymph node identification work in finding lymph node metastases in patients with stage IB1 cervical cancer. Diagnostic procedures, such as lymph node mapping and sentinel lymph node identification, performed before and during surgery, may improve the ability to detect lymph node metastases in patients who have cervical cancer.
Status | Terminated |
Enrollment | 102 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Diagnosis of carcinoma of the cervix of 1 of the following cellular types: - Squamous cell carcinoma - Adenocarcinoma - Adenosquamous cell carcinoma - Stage IB1 disease (no greater than 4 cm) - No unequivocal evidence of metastases - Adequate surgical candidate - No known allergy to triphenylmethane compounds - No prior pelvic irradiation - No prior retroperitoneal surgery - More than 4 weeks since prior cold knife or loop electrosurgical excision procedure (LEEP) cone biopsy - Prior cone biopsy allowed provided current disease is stage IB1 |
Country | Name | City | State |
---|---|---|---|
United States | Gynecologic Oncology Group | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Gynecologic Oncology Group | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity | Sensitivity is defined as the proportion of patients who test as positive sentinel node among the patients who have lymph node metastases. | At the time of surgery | |
Primary | False Negative Predictive Value (FNPV) | The proportion of patients with FNPV among patients who tests as negative sentinel node, where FNPV is defined as a person who tests as negative sentinel node but who actually has lymph node metastases | At the time of Surgery |
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