Clinical trial NCT04272190: Effect of Different Treatments on the Prognosis of Early Cervical Cancer: A Multicenter, Prospective, Real-world Study
Official title: Effect of Different Treatments on the Prognosis of Early Cervical Cancer: A Multicenter, Prospective, Real-world Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Keywords: Cervical cancer
Preoperative treatment
Surgical approach
Hysterectomy type
Radiochemotherapy
Lead sponsor: Southern Medical University, China
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 20000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cervical cancer patients

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 60 months from primary treatment
measure: disease-free survival (DFS)
timeFrame: 60 months from primary treatment
Secondary outcomes:
measure: Patterns of recurrence
timeFrame: 60 months from primary treatment
measure: Costs of treatment
timeFrame: 60 months from primary treatment
measure: Costs of readmission
timeFrame: 60 months from primary treatment
measure: Quality of life Questionnaires
timeFrame: 60 months from primary treatment
measure: The morbidity of sexual dysfunction
timeFrame: 60 months from primary treatment
measure: Intra-operative, peri-operative, post-operative and long term treatment related morbidity
timeFrame: 60 months from primary treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Chen Chunlin, PhD
role: PRINCIPAL_INVESTIGATOR
References: