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NCT Number: NCT07240753

A Chinese Cohort of Cervical Large Cell Neuroendocrine Carcinoma

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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Exclusion criteria

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

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Treatment and study plan

Postoperative pathological examination confirmed cervical large cell neuroendocrine carcinoma.

Other

Postoperative pathological examination confirmed cervical large cell neuroendocrine carcinoma.

Primary outcomes

  1. Overall Survival

    Time frame: One month post-enrollment completion and then annual follow-up

  2. Disease Recurrence

    Time frame: One month post-enrollment completion and then annual follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Lin Shitong Doctor

CONTACT

[email protected]

86 02783662379

Sponsors and collaborators

Lead sponsor

Lili

Other

Collaborators

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

Registry information

Official study title

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

Acronym: CN-CLCNEC

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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