Comparison of Screening Tests in Detecting Cervical Neoplasia
Ключови думи
Резюме
Описание
OBJECTIVES:
- Compare the sensitivity and specificity of primary screening strategies for the detection of cervical intraepithelial or invasive neoplasia.
- Compare the positive and negative predictive values of these strategies.
OUTLINE: This is a multicenter study. Patients are stratified according to the reason for the visit (general gynecological screening vs colposcopy referral).
- Stratum 1 (general gynecological screening): Patients undergo Pap smear, visual inspection aided by acetic acid (VIA), a colposcopy, and finally a visual inspection aided by toluidine blue (VIT) followed by an acetic acid wash. A biopsy may be performed at this initial visit. Within 2-3 weeks, patients are notified of results.
- Stratum 2 (colposcopy referral): Patients undergo Pap smear, VIA, colposcopy, VIT, and possible biopsy as in stratum 1. During the same visit, patients receive histologic evaluation and treatment with See-and-Treat loop electrosurgical excision procedure and/or endocervical curettage.
PROJECTED ACCRUAL: A total of 600-1,000 patients (300-500 per stratum) will be accrued for this study.
Дати
| Последна проверка: | 06/30/2012 |
| Първо изпратено: | 06/05/2002 |
| Очаквано записване подадено: | 01/25/2003 |
| Първо публикувано: | 01/26/2003 |
| Изпратена последна актуализация: | 07/29/2020 |
| Последна актуализация публикувана: | 08/02/2020 |
| Действителна начална дата на проучването: | 11/30/1999 |
| Приблизителна дата на първично завършване: | 07/31/2003 |
| Очаквана дата на завършване на проучването: | 03/31/2010 |
Състояние или заболяване
Интервенция / лечение
Other: Papanicolaou test
Other: cytology specimen collection procedure
Procedure: annual screening
Procedure: colposcopic biopsy
Procedure: comparison of screening methods
Фаза
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | Female |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria:: - History of cervical neoplasia - Presenting for a well-woman visit, annual Pap smear, or family planning - Other gynecological or non-gynecological complaints allowed OR - Referred for colposcopy secondary to an abnormal Pap smear - Planned screening for cervical cancer - Over 18 years of age - Prior laser surgery, cryotherapy, or conization or loop electrosurgical excision procedure for cervical neoplasia allowed Exclusion Criteria: - bleeding diathesis - pregnant - prior hysterectomy - concurrent anticoagulants |
