NCT04272190

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

5 years

First QC Date

February 11, 2020

Last Update Submit

February 14, 2020

Conditions

Cervical Cancer

Keywords

Cervical cancerPreoperative treatmentSurgical approachHysterectomy typeRadiochemotherapy

Outcome Measures

Primary Outcomes (2)

  • Overall survival (OS)

    Overall survival was defined as the period from initial treatment until cervical cancer related death.

    60 months from primary treatment

  • disease-free survival (DFS)

    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 Outcomes (6)

  • Patterns of recurrence

    60 months from primary treatment

  • Costs of treatment

    60 months from primary treatment

  • Costs of readmission

    60 months from primary treatment

  • Quality of life Questionnaires

    60 months from primary treatment

  • The morbidity of sexual dysfunction

    60 months from primary treatment

  • +1 more secondary outcomes

Interventions

clinical routine treatmentsOTHER

The cohort stratified by four factors: preoperative treatment (not received, neoadjuvant chemotherapy, preoperative radiotherapy); surgical approach (laparoscopic, abdominal, vaginal, robotic); hysterectomy types (type A, type B, type C1, type C2), primary treatment (Radical hysterectomy + pelvic lymph node dissectionp; radiochemotherapy)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cervical cancer patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Chen Chunlin, PhD

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Chunlin, PhD

CONTACT

13725263051ccl1@smu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
60 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 17, 2020

Study Start

June 1, 2020

Primary Completion

June 1, 2025

Study Completion

January 1, 2026

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

CN(1)