NCT04939831 Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2)
| NCT ID | NCT04939831 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Obstetrics & Gynecology Hospital of Fudan University |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,104 participants |
| Start Date | 2021-05-12 |
| Primary Completion | 2024-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,104 participants in total. It began in 2021-05-12 with a primary completion date of 2024-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in patient survival for Cervical Cancer (Stage IB3, IIA2).
Eligibility Criteria
Inclusion Criteria: 1. Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (Stage IB3,IIA2). 2. Age ≥ 21 years and ≤ 70 years. 3. Surgery type B and C (refer to Q-M surgical staging) 4. Normal range of liver and kidney function and blood count (specific details below) Hemoglobin \> 60g/L Platelets \> 70\*109/L Leukocytes \> 3\*109/L Creatinine \< 50mg/dL Transaminase abnormal indicators ≤ 3 Maximum value of transaminases not exceeding 3 times the corresponding normal value. 5. No history of other malignancies. 6. Non-pregnancy. 7. Physical strength classification: Karnofsky score ≥ 60; 8. Subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up. 9. No psychiatric disorders and other serious immune system disorders (e.g. lupus erythematosus, myasthenia gravis, HIV infection, etc.) (Note: Maximum diameter measurement of cervical lesions is based on PET-CT, or CT, or MRI) Exclusion Criteria: 1. Those who are contraindicated for various surgeries and cannot undergo surgery. 2. Patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer. 3. Patients with recurrent cervical cancer 4. Patients with CT, MRI or PET-CT suggesting suspicious metastasis of pelvic lymph nodes with maximum diameter \>2cm after further improvement of preoperative examination.
Contact & Investigator
Hua Jiang, PHD
PRINCIPAL INVESTIGATOR
The Obstetrics and Gynecology Hospital of Fudan University
Frequently Asked Questions
Who can join the NCT04939831 clinical trial?
This trial is open to female participants only, aged 21 Years or older, up to 70 Years, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04939831 currently recruiting?
Yes, NCT04939831 is actively recruiting participants. Contact the research team at jianghua@fudan.edu.cn for enrollment information.
Where is the NCT04939831 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04939831 clinical trial?
NCT04939831 is sponsored by Obstetrics & Gynecology Hospital of Fudan University. The principal investigator is Hua Jiang, PHD at The Obstetrics and Gynecology Hospital of Fudan University. The trial plans to enroll 1,104 participants.
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