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:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT01639820
Eligibility Criteria:
Inclusion Criteria:
* Women 18 years of age or older,
* Absence of contraindication to laparoscopy,
* Uterine cervical carcinoma (every histological type except neuroendocrine),
* Stage IA1 with lymphatic tumor space involvement (LVSI) or IA2 diagnosed on cervical conization; or stage IA2, IB1 or IIA detected by clinical examination, confirmed by biopsy and measured by the MRI, the highest diameter being lower to 4 cm (a preoperative brachytherapy is allowed for tumors 2 to 4 cm in diameter),
* Negative pregnancy test for women able to procreate,
* Having the French National Social Security
* Signed informed consent
Exclusion Criteria:
* Neuroendocrine carcinoma,
* In situ carcinoma or stage IA1 without LVSI,
* Maximal tumoral diameter measured by MRI more than 4 cm,
* Stage IB1 by "down-staging",
* Stage IB2, IIB to IVB, including those who had a response to neoadjuvant treatment (chemotherapy or RT + chemotherapy) ,
* Presence of distant metastases,
* Progression of the cervical cancer or recurrence,
* History of pelvic lymphadenectomy,
* Other cancer diagnosed during the course of treatment,
* Contraindication to the injected products : allergy known to Patent Blue or rhenium sulfide,
* History of severe allergy (history of Quincke's edema, anaphylactic shock),
* Patient who does not understand, speak or write the French language,
* Pregnant woman
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01639820
Study Brief:
Protocol Section:
NCT01639820