A Chinese Cohort of Cervical Large Cell Neuroendocrine Carcinoma (CN-CLCNEC)

November 15, 2025 updated by: Lili

Clinical Characteristics and Prognostic Factors of Large Cell Neuroendocrine Carcinoma of the Cervix: A Multicenter, Bidirectional Cohort Study

Cervical large cell neuroendocrine carcinoma (LCNEC) exhibits highly aggressive biological behavior, including strong invasiveness, a high propensity for metastasis, drug resistance, and poor prognosis, necessitating heightened clinical and pathological awareness. This study aims to summarize the clinical characteristics of LCNEC and analyze various prognostic factors to enhance understanding and vigilance toward this disease. Combined with precise pathological diagnosis, improving diagnostic accuracy is crucial for formulating treatment strategies and assessing patient prognosis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will collect the complete medical records of patients with cervical large cell neuroendocrine carcinoma registered in the participating tertiary hospitals, and will prospectively collect the medical records of patients diagnosed with cervical large cell carcinoma. The data to be collected includes:

  • Patient demographics (age, place of origin, occupation, etc.)
  • Medical history and test results prior to initial treatment:
  • Present illness history
  • Tumor marker levels
  • Pelvic ultrasound
  • Whole abdomen CT/MRI
  • PET-CT
  • Surgical treatment details (date of surgery, surgical approach)
  • Pathological examination results
  • Administration of neoadjuvant chemotherapy and/or radiotherapy
  • Detailed records of all treatment courses and their efficacy (including chemotherapeutic agents, radiotherapy doses, number of cycles, etc.)
  • Results from follow-up examinations and imaging studies
  • Recurrence status and, if applicable, time to recurrence
  • Survival status and, if applicable, date of death For the retrospective cohort, follow-up will be completed within one month after enrollment to document current survival status and recurrence. For the prospective cohort, annual follow-ups will be conducted to record current survival status and recurrence.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Female patients diagnosed with cervical large cell neuroendocrine carcinoma by postoperative histopathological examination.

Description

Inclusion Criteria: The diagnosis of cervical large cell neuroendocrine carcinoma (LCNEC) was confirmed by histopathological examination, meeting both clinical and histological criteria. The tumor exhibited characteristic features, including large cells with abundant cytoplasm, vesicular nuclei with prominent nucleoli, and a high mitotic rate (>10 mitoses/10 HPFs). The growth patterns were predominantly insular, trabecular, or solid, often accompanied by peripheral palisading or rosette formation, along with focal tumor necrosis.

-

Exclusion Criteria: Mixed cervical LCNEC histology, cases with missing follow-up, or patients lost to contact.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cervical Large Cell Neuroendocrine Carcinoma Cohort
Other: Postoperative pathological examination confirmed cervical large cell neuroendocrine carcinoma.
Postoperative pathological examination confirmed cervical large cell neuroendocrine carcinoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: One month post-enrollment completion and then annual follow-up
One month post-enrollment completion and then annual follow-up
Disease Recurrence
Time Frame: One month post-enrollment completion and then annual follow-up
One month post-enrollment completion and then annual follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lili

Collaborators

Zhejiang Cancer Hospital
The First Affiliated Hospital of Anhui Medical University
Peking Union Medical College Hospital
Qilu Hospital of Shandong University
Tianjin Medical University Cancer Institute and Hospital
The First Affiliated Hospital of Zhengzhou University
Women's Hospital School Of Medicine Zhejiang University
Renmin Hospital of Wuhan University
Obstetrics & Gynecology Hospital of Fudan University
Fujian Maternity and Child Health Hospital
The Third Affiliated Hospital of Kunming Medical College.
Fujian Province Tumor Hospital
The Affiliated Tumor Hospital of Xinjiang Medical University
Cancer Research Institute of Zhongshan City
National Cancer Center/National Cancer Clinical Medical Research Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

November 15, 2025

First Submitted That Met QC Criteria

November 15, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 15, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-IRB202506084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It involves highly confidential personal information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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