Protein Molecular Characteristics and Prognosis of Cervic... | NCT06276309

Studies
Protein Molecular Characteristics and Prognosis of Cervical Neuroendocrine Tumors

NCT06276309

Sponsor

Fujian Maternity and Child Health Hospital

Status

Recruiting

Last Update Posted

Sep 19, 2024Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Neuroendocrine Neoplasm
China
Women
Cervical Cancer
Cervical Lesion

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2024Actual

Primary Completion Date

Dec 30, 2024Estimated

Completion Date

Feb 28, 2025Estimated

First Submitted Date

Feb 7, 2024

First Submission Date that Met QC Criteria

Feb 21, 2024

First Posted Date

Feb 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2024

Last Update Posted Date

Sep 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality rate	3-year mortality rate for cervical neuroendocrine carcinoma	Among patients with cervical neuroendocrine carcinoma, the mortality rate within 3 years following surgery
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with cervical neuroendocrine carcinoma by histopathology
Clinical data were complete

Exclusion Criteria:

Patients who are not being treated in our hospital
Patients with lack of follow-up data, unable to obtain survival information
Patients call to refuse to participate in this project
The quality of paraffin specimens can not meet the requirements of proteome concentration determination

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All 300 patients were diagnosed with cervical neuroendocrine carcinoma by histopathology

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Binhua Dong	Contact	+86-0591-87558732		dongbinhua86@fjmu.edu.cn
Pengming Sun	Contact			fmsun1975@fjmu.edu.cn

Overall Officials

Name	Affiliation	Role
Pengming Sun, PhD	Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fujian Maternity and Child Health Hospital	Recruiting	Fuzhou	Fujian	350001	China

Condition Browse Module

MeSH Terms

ID	Term
D018358	Neuroendocrine Tumors
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.