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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06276309
Other study ID # NECC2401
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2024
Est. completion date June 30, 2024

Study information

Verified date February 2024
Source Fujian Maternity and Child Health Hospital
Contact Binhua Dong
Phone +86-0591-87558732
Email dongbinhua86@fjmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The clinical diagnosis and treatment data of 300 cases of cervical neuroendocrine tumors were collected, including age, preoperative biopsy pathology results, postoperative histopathological results, TCT results, and colposcopy biopsy pathology results. At the same time, paraffin tissue specimens (remaining specimens after pathological diagnosis) from 100 cases of cervical neuroendocrine tumors from multiple centers across the country were collected to establish a cervical neuroendocrine tumor data follow-up database. Protein concentration and omics analysis were performed on the data results, to evaluate the molecular characteristics and prognosis of cervical neuroendocrine tumor proteins, and to preliminarily explore its clinical application value.


Description:

1. The clinical diagnosis and treatment data of 300 cases of cervical neuroendocrine tumors were used for prognostic analysis. (1) The diagnosis and treatment information of cervical neuroendocrine carcinoma in multiple hospitals was collected, including clinical and medical data such as age, preoperative HPV genotyping, preoperative biopsy pathological results, postoperative histopathological results, FIGO staging, prognosis and survival information, and follow-up of patients. 2. Protein and other omics analysis was performed on paraffin tissues of 100 cases of cervical neuroendocrine tumors Paraffin samples collected from 100 cases of cervical neuroendocrine tumors were identified, processed and segmtioned, and protein concentration and proteome were determined to establish the molecular characteristics and prognostic targets of cervical neuroendocrine tumors.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: 1. Patients diagnosed with cervical neuroendocrine carcinoma by histopathology 2. Clinical data were complete Exclusion Criteria: 1. Patients who are not being treated in our hospital 2. Patients with lack of follow-up data, unable to obtain survival information 3. Patients call to refuse to participate in this project 4. The quality of paraffin specimens can not meet the requirements of proteome concentration determination

Study Design


Locations

Country Name City State
China Xiangya Hospital, Central South University Changsha Hunan
China Fujian Maternity and Child Health Hospital Fuzhou Fujian
China Fujian Provincial Hospital Fuzhou Fujian
China Jiangxi maternal and Child Health Hospital Nanchang Jiangxi
China Ningde Mindong Hospital Ningde Fujian
China Putian City first Hospital Putian Fujian
China The Second Affiliated Hospital of Fujian Medical University Quanzhou Fujian
China Maternal and Child Health Hospital of Hubei Province Wuhan Hubei
China Zhangzhou affiliated Hospital of Fujian Medical University Zhangzhou Fujian

Sponsors (1)

Lead Sponsor Collaborator
Fujian Maternity and Child Health Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary mortality rate 3-year mortality rate for cervical neuroendocrine carcinoma Among patients with cervical neuroendocrine carcinoma, the mortality rate within 3 years following surgery
Primary Disease-free survival 3-year disease-free survival for cervical neuroendocrine carcinoma Among patients with cervical neuroendocrine carcinoma, the disease-free survival within 3 years following surgery
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