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Different Surgical Approaches in Patients of Early-stage Cervical Cancer

NCT03739944UNKNOWNPHASE3INTERVENTIONAL

Summary

This multi-center, randomized controlled study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between Chinese uterine cervical patients receiving different surgical routes (laparotomy and laparoscopy) for radical hysterectomy or trachelectomy, which is the primary study objective. All patients with uterine cervical cancer of FIGO stage IA1 (with lymphovascular space invasion), IA2 and IB1 will be included and randomized into two groups: laparotomy and laparoscopy groups for radical hysterectomy or trachelectomy. Secondary study objectives include: patterns of recurrence, treatment-associated morbidity (6 months from surgery), cost-effectiveness, pelvic floor function, and quality of life.

Key Facts

Lead Sponsor

Lei Li

Enrollment

700

Start Date

2018-11-23

Completion Date

2022-11-23

Study Type

INTERVENTIONAL

Official Title

Randomized Trial of Different Surgical Approaches in Patients of Chinese Early-stage Cervical Cancer

Interventions

Laparotomic radical hysterectomyLaparotomic radical trachelectomyLaparoscopic radical hysterectomyLaparoscopic radical trachelectomy

Conditions

Uterine Cervical NeoplasmLaparotomyLaparoscopySurvivalMortalityMorbidityQuality of LifePelvic Floor DisordersCost-Benefit Analysis

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix
* FIGO stage IA1 (with lymphovascular space invasion), IA2 or IB1
* Type II or III radical hysterectomy or trachelectomy
* Performance status of ECOG 0-1
* Aged 18 years or older
* Signed an approved informed consents

Exclusion Criteria:

* Not satisfying any of the inclusion criteria

Outcome Measures

Primary Outcomes

Progression-free survival

The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

Time frame: Five years

Secondary Outcomes

Overall survival

The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.

Time frame: Five years

Disease-free survival

In cancer, the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.

Time frame: Five years

Morbidity rate

Refers to having a disease or a symptom of disease, or to the amount of disease within a population. In this study, morbidity of six months from the surgery is defined according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03

Time frame: Six months

Locations

Lei Li, Beijing, China

Linked Papers

2020-12-14

Minimally invasive versus open radical trachelectomy for early-stage cervical cancer: protocol for a multicenter randomized controlled trial in China

Abstract Background There are limited data comparing the oncologic and fertility outcomes of patients with early-stage cervical cancer (CC) treated by minimally invasive radical trachelectomy (MIRT) or abdominal radical trachelectomy (ART). The purpose of this multicenter study is to compare the oncologic and fertility outcomes of patients treated by MIRT or ART in a randomized controlled manner in China. Methods This is a noninferiority, randomized controlled trial performed at 28 Chinese centers; the study is designed to compare the oncologic and fertility outcomes of patients treated by MIRT (robot-assisted or laparoscopic RT) or ART. Patients will be recruited if they have been diagnosed with stage IA1 (with lymphovascular space invasion), IA2, or IB1 CC (with a maximum tumor diameter ≤ 2 cm) in the FIGO 2009 staging system and histological subtypes of squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma and if they are also aged 18 to 40 years. These candidates will be randomly assigned to undergo MIRT or ART. The primary endpoint will be disease-free survival. Secondary endpoints will consist of overall and disease-free survival rates, fertility outcomes, and quality of life. A total of 414 patients are needed to accomplish the study goal, with 90.1% power at a 0.050 significance level to detect an equivalence hazard ratio of 0.75 in the ART group, considering 20% loss to follow-up. Discussion The results of the trial should provide robust evidence to surgeons regarding options for the surgical approach in patients with early-stage CC who have a strong willingness to preserve fertility. Trial registration ClinicalTrials.gov NCT03739944. Registered on November 14, 2018

Minimally invasive surgery and quality of life in cervical cancer

Linked Investigators

Lei Li