Neuroendocrine NeoplasmNCT06276309
Protein Molecular Characteristics and Prognosis of Cervical Neuroendocrine Tumors
An observational study of Neuroendocrine Neoplasm and China, run by Fujian Maternity and Child Health Hospital at 9 sites in China.
Trial summary
The clinical diagnosis and treatment data of 300 cases of cervical neuroendocrine tumors were collected, including age, preoperative biopsy pathology results, postoperative histopathological results, TCT results, and colposcopy biopsy pathology results. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Neuroendocrine Neoplasm, China, Women
- How many people
- 300 participants
- Where
- 9 sitesChina
- Study dates
- 1 Feb 2024to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All 300 patients were diagnosed with cervical neuroendocrine carcinoma by histopathology
Who may be able to join
- Patients diagnosed with cervical neuroendocrine carcinoma by histopathology
- Clinical data were complete
Who cannot join
- Patients who are not being treated in our hospital
- Patients with lack of follow-up data, unable to obtain survival information
- Patients call to refuse to participate in this project
- The quality of paraffin specimens can not meet the requirements of proteome concentration determination
Trial locations and contacts
9 sites in 1 country.
Pengming Sun contact
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Xiangya Hospital, Central South University
Changsha, Hunan
Yu Zhang
- Recruiting
Fujian Maternity and Child Health Hospital
Fuzhou, Fujian, 350001
Binhua Dong, +8687558732, dbh18-jy@126.com
- Recruiting
Fujian Provincial Hospital
Fuzhou, Fujian
Dongjie Chen
- Recruiting
Jiangxi maternal and Child Health Hospital
Nanchang, Jiangxi
Ling Li
- Recruiting
Ningde Mindong Hospital
Ningde, Fujian
Fang Xie
- Recruiting
Putian City first Hospital
Putian, Fujian
Yi Chen
- Recruiting
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian
Luhong Li
- Recruiting
Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei
Hongning Cai, M.D, +8615926224867
- Recruiting
Zhangzhou affiliated Hospital of Fujian Medical University
Zhangzhou, Fujian, 363000
Feifeng Shi, M.D
About this study
The clinical diagnosis and treatment data of 300 cases of cervical neuroendocrine tumors were collected, including age, preoperative biopsy pathology results, postoperative histopathological results, TCT results, and colposcopy biopsy pathology results. At the same time, paraffin tissue specimens (remaining specimens after pathological diagnosis) from 100 cases of cervical neuroendocrine tumors from multiple centers across the country were collected to establish a cervical neuroendocrine tumor data follow-up database. Protein concentration and omics analysis were performed on the data results, to evaluate the molecular characteristics and prognosis of cervical neuroendocrine tumor proteins, and to preliminarily explore its clinical application value.
Read the detailed description
- The clinical diagnosis and treatment data of 300 cases of cervical neuroendocrine tumors were used for prognostic analysis. (1) The diagnosis and treatment information of cervical neuroendocrine carcinoma in multiple hospitals was collected, including clinical and medical data such as age, preoperative HPV genotyping, preoperative biopsy pathological results, postoperative histopathological results, FIGO staging, prognosis and survival information, and follow-up of patients.
- Protein and other omics analysis was performed on paraffin tissues of 100 cases of cervical neuroendocrine tumors Paraffin samples collected from 100 cases of cervical neuroendocrine tumors were identified, processed and segmtioned, and protein concentration and proteome were determined to establish the molecular characteristics and prognostic targets of cervical neuroendocrine tumors.
- Conditions
- Neuroendocrine Neoplasm, China, Women, Cervical Cancer, Cervical Lesion
- Medical subject headings
- Neuroendocrine Tumors, Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
3-year mortality rate for cervical neuroendocrine carcinoma
Measured: Among patients with cervical neuroendocrine carcinoma, the mortality rate within 3 years following surgery
Disease-free survival
3-year disease-free survival for cervical neuroendocrine carcinoma
Measured: Among patients with cervical neuroendocrine carcinoma, the disease-free survival within 3 years following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Feb 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine NeoplasmStudies 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pengming Sun, PhD, Study chair, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276309
- Sponsor's protocol ID
- NECC2401
- Status last verified
- Sep 2024
- First submitted
- 7 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Molecular Characteristics and Prognosis of Cervical Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT06276309
- Acronym / sponsor ID
- NECC2401
- Conditions
- Neuroendocrine Neoplasm, China, Women, Cervical Cancer, Cervical Lesion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fujian Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 23 Feb 2024 (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.
The clinical diagnosis and treatment data of 300 cases of cervical neuroendocrine tumors were collected, including age, preoperative biopsy pathology results, postoperative histopathological results, TCT results, and colposcopy biopsy pathology results. At the same time, paraffin tissue specimens (remaining specimens after pathological diagnosis) from 100 cases of cervical neuroendocrine tumors from multiple centers across the country were collected to establish a cervical neuroendocrine tumor data follow-up database. Protein concentration and omics analysis were performed on the data results, to evaluate the molecular characteristics and prognosis of cervical neuroendocrine tumor proteins, and to preliminarily explore its clinical application value.
Detailed description
- The clinical diagnosis and treatment data of 300 cases of cervical neuroendocrine tumors were used for prognostic analysis. (1) The diagnosis and treatment information of cervical neuroendocrine carcinoma in multiple hospitals was collected, including clinical and medical data such as age, preoperative HPV genotyping, preoperative biopsy pathological results, postoperative histopathological results, FIGO staging, prognosis and survival information, and follow-up of patients.
- Protein and other omics analysis was performed on paraffin tissues of 100 cases of cervical neuroendocrine tumors Paraffin samples collected from 100 cases of cervical neuroendocrine tumors were identified, processed and segmtioned, and protein concentration and proteome were determined to establish the molecular characteristics and prognostic targets of cervical neuroendocrine tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All 300 patients were diagnosed with cervical neuroendocrine carcinoma by histopathology
Key inclusion criteria (2 listed)
- Patients diagnosed with cervical neuroendocrine carcinoma by histopathology
- Clinical data were complete
Key exclusion criteria (4 listed)
- Patients who are not being treated in our hospital
- Patients with lack of follow-up data, unable to obtain survival information
- Patients call to refuse to participate in this project
- The quality of paraffin specimens can not meet the requirements of proteome concentration determination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality rate
Time frame: Among patients with cervical neuroendocrine carcinoma, the mortality rate within 3 years following surgery
3-year mortality rate for cervical neuroendocrine carcinoma
Disease-free survival
Time frame: Among patients with cervical neuroendocrine carcinoma, the disease-free survival within 3 years following surgery
3-year disease-free survival for cervical neuroendocrine carcinoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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. This study is not recruiting at the moment.
Pengming Sun contact
Pengming Sun, PhD study chair
Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Neoplasm and China, run by Fujian Maternity and Child Health Hospital at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Binhua Dong (+86-0591-87558732, dongbinhua86@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality rate (time frame: Among patients with cervical neuroendocrine carcinoma, the mortality rate within 3 years following surgery). 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?
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 19 Sep 2024.