Uterine Cervical NeoplasmsCN-CLCNECNCT07240753
A Chinese Cohort of Cervical Large Cell Neuroendocrine Carcinoma
An observational study of Uterine Cervical Neoplasms, run by Lili.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- Postoperative pathological examination confirmed cervical large cell neuroendocrine carcinoma.
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Female patients diagnosed with cervical large cell neuroendocrine carcinoma by postoperative histopathological examination.
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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Uterine Cervical Neoplasms
- Being tested
- Postoperative pathological examination confirmed cervical large cell neuroendocrine carcinoma.
- Keywords
- Cervical Large Cell Neuroendocrine Carcinoma, Prognosis, High-Risk Factors, Treatment Options
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative pathological examination confirmed cervical large cell neuroendocrine carcinoma.Other
Postoperative pathological examination confirmed cervical large cell neuroendocrine carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Large Cell Neuroendocrine Carcinoma Cohort | Not described Receives: Other: Postoperative pathological examination confirmed cervical large cell neuroendocrine carcinoma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: One month post-enrollment completion and then annual follow-up
Disease Recurrence
Measured: One month post-enrollment completion and then annual follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lili
- Sponsor type
- University, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Cancer Research Institute of Zhongshan City, The First Affiliated Hospital of Zhengzhou University, Qilu Hospital of Shandong University, Fujian Province Tumor Hospital, Fujian Maternity and Child Health Hospital, Zhejiang Cancer Hospital, The Third Affiliated Hospital of Kunming Medical College., Obstetrics & Gynecology Hospital of Fudan University, Women's Hospital School Of Medicine Zhejiang University, National Cancer Center, China, Peking Union Medical College Hospital, Third Affiliated Hospital of Xinjiang Medical University, The First Affiliated Hospital of Anhui Medical University, Tianjin Medical University Cancer Institute and Hospital, Renmin Hospital of Wuhan University
- Responsible party
- Sponsor-investigator, Lili, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240753
- Sponsor's protocol ID
- TJ-IRB202506084
- Acronym
- CN-CLCNEC
- Status last verified
- Jun 2025
- First submitted
- 15 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It involves highly confidential personal information.
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.
PubMed 33802174Georgescu 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.
PubMed 34946283Xu 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.
PubMed 35778245Salvo 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.
PubMed 31263021Lee 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.
PubMed 30483095Caruso 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.
PubMed 33933568
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Prognostic Factors of Large Cell Neuroendocrine Carcinoma of the Cervix: A Multicenter, Bidirectional Cohort Study
- ClinicalTrials.gov ID
- NCT07240753
- Acronym / sponsor ID
- CN-CLCNEC / TJ-IRB202506084
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- Cervical Large Cell Neuroendocrine Carcinoma, Prognosis, High-Risk Factors, Treatment Options
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- LiliUniversity, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Cancer Research Institute of Zhongshan City, The First Affiliated Hospital of Zhengzhou University, Qilu Hospital of Shandong University, Fujian Province Tumor Hospital, Fujian Maternity and Child Health Hospital, Zhejiang Cancer Hospital, The Third Affiliated Hospital of Kunming Medical College., Obstetrics & Gynecology Hospital of Fudan University, Women's Hospital School Of Medicine Zhejiang University, National Cancer Center, China, Peking Union Medical College Hospital, Third Affiliated Hospital of Xinjiang Medical University, The First Affiliated Hospital of Anhui Medical University, Tianjin Medical University Cancer Institute and Hospital, Renmin Hospital of Wuhan University
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical Large Cell Neuroendocrine Carcinoma Cohort | – | Other: Postoperative pathological examination confirmed cervical large cell neuroendocrine carcinoma. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female patients diagnosed with cervical large cell neuroendocrine carcinoma by postoperative histopathological examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative pathological examination confirmed cervical large cell neuroendocrine carcinoma.Postoperative pathological examination confirmed cervical large cell neuroendocrine carcinoma. | Other | Cervical Large Cell Neuroendocrine Carcinoma Cohort |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Background: PubMed 33802174Takayanagi 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.
- Background: PubMed 34946283Georgescu 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.
- Background: PubMed 35778245Xu 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.
- Background: PubMed 31263021Salvo 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.
- Background: PubMed 30483095Lee 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.
- Background: PubMed 33933568Caruso 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.
- Individual participant dataSharing planned: Undecided. It involves highly confidential personal information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Cervical Neoplasms, run by Lili.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lin Shitong Doctor (86 02783662379, 1131108208@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: One month post-enrollment completion and then annual follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07240753, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.