A Chinese Cohort of Cervical Large Cell Neuroendocrine Carcinoma

Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

• Overall Survival [Time frame: One month post-enrollment completion and then annual follow-up]
• Disease Recurrence [Time frame: One month post-enrollment completion and then annual follow-up]

Eligibility 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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Takayanagi D, Hirose S, Kuno I, Asami Y, Murakami N, Matsuda M, Shimada Y, Sunami K, Komatsu M, Hamamoto R, Kato MK, Matsumoto K, Kohno T, Kato T, Shiraishi K, Yoshida H. Comparative Analysis of Genetic Alterations, HPV-Status, and PD-L1 Expression in Neuroendocrine Carcinomas of the Cervix. Cancers (Basel). 2021 Mar 10;13(6):1215. doi: 10.3390/cancers13061215. PMID 33802174
• Georgescu TA, Bohiltea RE, Munteanu O, Furtunescu F, Lisievici AC, Grigoriu C, Gherghiceanu F, Vladareanu EM, Berceanu C, Ducu I, Iordache AM. Emerging Therapeutic Concepts and Latest Diagnostic Advancements Regarding Neuroendocrine Tumors of the Gynecologic Tract. Medicina (Kaunas). 2021 Dec 7;57(12):1338. doi: 10.3390/medicina57121338. PMID 34946283
• Xu F, Yu Q, Wan D, Zhang Y. Cervical adenocarcinoma admixing with large cell neuroendocrine carcinoma: A rare case report. Asian J Surg. 2022 Dec;45(12):2932-2933. doi: 10.1016/j.asjsur.2022.06.109. Epub 2022 Jun 29. No abstract available. PMID 35778245
• Salvo G, Gonzalez Martin A, Gonzales NR, Frumovitz M. Updates and management algorithm for neuroendocrine tumors of the uterine cervix. Int J Gynecol Cancer. 2019 Jul;29(6):986-995. doi: 10.1136/ijgc-2019-000504. PMID 31263021
• Lee E, Ji YI. Large Cell Neuroendocrine Carcinoma of the Cervix with Sequential Metastasis to Different Sites: A Case Report. Case Rep Oncol. 2018 Oct 23;11(3):665-670. doi: 10.1159/000493912. eCollection 2018 Sep-Dec. PMID 30483095
• Caruso G, Sassu CM, Tomao F, Di Donato V, Perniola G, Fischetti M, Benedetti Panici P, Palaia I. The puzzle of gynecologic neuroendocrine carcinomas: State of the art and future directions. Crit Rev Oncol Hematol. 2021 Jun;162:103344. doi: 10.1016/j.critrevonc.2021.103344. Epub 2021 Apr 29. PMID 33933568

Identifiers

NCT: NCT07240753 · TJ-IRB202506084

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗