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

Lili

Status: Not yet enrolling

Conditions: Uterine Cervical Neoplasms

Treatments: Other: Postoperative pathological examination confirmed cervical large cell neuroendocrine carcinoma.

Study type: Observational

Funder types: Other

Identifiers

NCT07240753

TJ-IRB202506084

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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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Trial design

200 participants in 1 patient group

Cervical Large Cell Neuroendocrine Carcinoma Cohort

Treatment:

Other: Postoperative pathological examination confirmed cervical large cell neuroendocrine carcinoma.