Clinical trial NCT06276309: Protein Molecular Characteristics and Prognosis of Cervical Neuroendocrine Tumors
Official title: Protein Molecular Characteristics and Prognosis of Cervical Neuroendocrine Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuroendocrine Neoplasm
China
Women
Cervical Cancer
Cervical Lesion
Lead sponsor: Fujian Maternity and Child Health Hospital
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All 300 patients were diagnosed with cervical neuroendocrine carcinoma by histopathology

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: mortality rate
timeFrame: Among patients with cervical neuroendocrine carcinoma, the mortality rate within 3 years following surgery
measure: Disease-free survival
timeFrame: Among patients with cervical neuroendocrine carcinoma, the disease-free survival within 3 years following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Maternity and Child Health Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Ningde
country: China
facility: Ningde Mindong Hospital
state: Fujian
city: Putian
country: China
facility: Putian City first Hospital
state: Fujian
city: Quanzhou
country: China
facility: The Second Affiliated Hospital of Fujian Medical University
state: Fujian
city: Zhangzhou
country: China
facility: Zhangzhou affiliated Hospital of Fujian Medical University
state: Fujian
city: Wuhan
country: China
facility: Maternal and Child Health Hospital of Hubei Province
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
city: Nanchang
country: China
facility: Jiangxi maternal and Child Health Hospital
state: Jiangxi
Study officials:
affiliation: Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University
name: Pengming Sun, PhD
role: STUDY_CHAIR
References: