Effect of Different Treatments on the Prognosis of Early Cervical Cancer: A Multicenter, Prospective, Real-world Study

February 14, 2020 updated by: Chen Chunlin, Southern Medical University, China
To observe the effects of different treatments on the oncological outcome and complications of early cervical cancer (2018 FIGO stage IA1 with lymphovascular space invasion and IA2-IIA2 cervical cancer). This study prospectively collecting enrolled cervical cancer patients clinical data and outcome from June 2020 to June 2025. (Classification factors: preoperative neoadjuvant treatment , surgical approach, type of hysterectomy, whether to receive radiochemotherapy) . This study is an observational study, and segmented analysis according to different treatment methods.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objectives: To observe the effects of different treatments on the oncological outcome and complications of early cervical cancer (2018 FIGO stage IA1 with lymphovascular space invasion and IA2-IIA2 cervical cancer).

Study Design: We obtained the demographic, clinical, treatment hospital and complication data of patients with cervical cancer undergoing radical hysterectomy from 2004 to 2015 at 37 hospitals. The patients were assigned into groups. Classification factors: preoperative neoadjuvant treatment (not received, neoadjuvant chemotherapy, preoperative radiotherapy) , surgical approach (abdomincal, laparoscopic, vaginal, robotic surgery), type of hysterectomy (type B, type C1, type C2), primary treatment (radiochemotherapy or surgery).

laparoscopic and abdominal surgery groups. The differences in the survival, complication rates, quality of life, and cost were analyzed using univariate and multivariable logistic regression models.

Study Type

Observational

Enrollment (Anticipated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital of Southern Medical University
        • Contact:
          • Li Wenyuan, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Cervical cancer patients

Description

Inclusion Criteria:

  1. Histologically confirmed primary adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, or other histological types carcinoma of the uterine cervix.
  2. Patients with Histologically confirmed stage IA1 (with lymph vascular invasion), FIGO 2018 stage IA2 to IIA2.
  3. Underwent radical hysterectomy or radiochemotherapy.
  4. ECOG Performance Status of 0 or 1.

Exclusion Criteria:

  1. Life expectancy is less than 6 months
  2. No prior malignancy
  3. ECOG Performance Status of 2 to 5.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 60 months from primary treatment
Overall survival was defined as the period from initial treatment until cervical cancer related death.
60 months from primary treatment
disease-free survival (DFS)
Time Frame: 60 months from primary treatment
Tumor-free survival was defined as the period from initial treatment until the recurrence or the date of last follow-up.
60 months from primary treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patterns of recurrence
Time Frame: 60 months from primary treatment
date and localization of 1st recurrence as confirmed histologically
60 months from primary treatment
Costs of treatment
Time Frame: 60 months from primary treatment
60 months from primary treatment
Costs of readmission
Time Frame: 60 months from primary treatment
60 months from primary treatment
Quality of life Questionnaires
Time Frame: 60 months from primary treatment
The European O-rganization for Reasearch and Treatment of Cance QLQ-30 Questionnaires to measure quality of life for any kind cancer patient. The Europe Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Cervical Cancer Module is a supplementary questionnaire for evaluating the quality of life of patients with cervical cancer.
60 months from primary treatment
The morbidity of sexual dysfunction
Time Frame: 60 months from primary treatment
Female Sexual Function Index (FSFI)
60 months from primary treatment
Intra-operative, peri-operative, post-operative and long term treatment related morbidity
Time Frame: 60 months from primary treatment
Complications of all the patients
60 months from primary treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern Medical University, China

Investigators

  • Principal Investigator: Chen Chunlin, PhD, Nanfang Hospital of Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2020

Primary Completion (ANTICIPATED)

June 1, 2025

Study Completion (ANTICIPATED)

January 1, 2026

Study Registration Dates

First Submitted

February 11, 2020

First Submitted That Met QC Criteria

February 14, 2020

First Posted (ACTUAL)

February 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 14, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2019-105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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