Cervical Neuroendocrine CarcinomaNCT07879339
Multi-omics Study of Cervical Neuroendocrine Carcinoma
An observational study of Cervical Neuroendocrine Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a retrospective study using archived tumor tissue and medical records from patients with cervical neuroendocrine carcinoma treated at Peking Union Medical College Hospital since January 1, 2015. Cervical neuroendocrine carcinoma is a rare and highly aggressive cervical cancer with no standard treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Cervical Neuroendocrine Carcinoma
- What is being tested?
- Multi-omics profiling of archived tumor tissue (observational)
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 30 Dec 2026
- 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 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study population comprises approximately 80-120 adult female patients (aged ≥18 years) with histologically confirmed cervical neuroendocrine carcinoma (NECC), including small cell, large cell, and mixed types, who were treated at Peking Union Medical College Hospital between January 1, 2015 and the present. Eligible patients have archived tumor tissue specimens (formalin-fixed paraffin-embedded or fresh-frozen) available for multi-omics testing and complete retrospective clinical data, including baseline characteristics, treatment information, efficacy and survival outcomes, and follow-up records. Patients with inadequate specimen quality for multi-omics testing, severely missing key clinical data, or concomitant other malignancies (excluding non-melanoma skin cancer) will be excluded.
Who may be able to join
- 1: Inclusion criteria Age ≥ 18 years
- 2: Histopathologically confirmed neuroendocrine carcinoma of the cervix (including small cell type, large cell type, and mixed type), reviewed and confirmed by at least two pathologists
- 3: Sufficient quality and quantity of archived tumor tissue specimens available for multi-omics testing (formalin-fixed paraffin-embedded tissue sections ≥ 10 slides or fresh frozen tissue ≥ 50 mg)
- 4: Complete clinical medical records and follow-up data (including at least diagnostic information, treatment regimen, and survival follow-up)
Who cannot join
- 1: Failure to meet all of the above inclusion criteria
- 2: Archived tumor tissue specimens of inadequate quality for multi-omics testing
- 3: Severely missing key clinical data that preclude the extraction of valid information
- 4: Concomitant other malignancies (excluding non-melanoma skin cancer)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital
Beijing, 100730
Lei Li, 86-139-1198-8831, lileigh@163.com
About this study
Official title: A Real-World Retrospective Multi-Omics Study of Cervical Neuroendocrine Carcinoma
This is a retrospective study using archived tumor tissue and medical records from patients with cervical neuroendocrine carcinoma treated at Peking Union Medical College Hospital since January 1, 2015. Cervical neuroendocrine carcinoma is a rare and highly aggressive cervical cancer with no standard treatment. The study will analyze the tumor's genes, RNA, proteins, and immune environment to better understand its molecular features, identify molecular subtypes, find markers related to survival and immunotherapy, and build a prognostic prediction model. No new patients will be enrolled, and no additional tests or treatments will be given. About 80-120 patients are expected to be included. Results may help improve future diagnosis and personalized treatment for this rare cancer.
- Conditions
- Cervical Neuroendocrine Carcinoma
- Being tested
- Multi-omics profiling of archived tumor tissue (observational)
- Keywords
- Neuroendocrine Carcinoma of Cervix, Multi-omics study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-omics profiling of archived tumor tissue (observational)Other
This is a retrospective, observational multi-omics study. No therapeutic intervention (drug, device, procedure, or behavioral modification) is administered to patients. The "intervention" in this context refers solely to the molecular profiling performed on archived tumor tissue specimens and the retrospective collection of clinical data. The multi-omics profiling includes whole-exome sequencing (WES) or large-panel targeted sequencing, strand-specific RNA sequencing, mass spectrometry-based proteomics, and multiplex immunofluorescence/immunohistochemistry (mIF/IHC). These assays are designed to comprehensively characterize the genomic, transcriptomic, proteomic, and tumor immune microenvironment landscape of cervical neuroendocrine carcinoma (NECC). This distinguishes the present study from others by its integrated multi-omics approach and focus on molecular subtyping, rather than evaluating a specific therapeutic agent.
| Study group | Role | What they receive |
|---|---|---|
| NECC Multi-Omics Retrospective Cohort | This is a single-center, retrospective cohort of approximately 80-120 patients with histologically confirmed cervical neuroendocrine carcinoma (NECC) treated at Peking Union Medical College Hospital since January 1, 2015. Eligible patients have archived tumor tissue (FFPE or fresh-frozen) and complete retrospective clinical follow-up data. No intervention is administered as part of this study. Archived specimens will undergo multi-omics testing, including whole-exome sequencing or large-panel targeted sequencing, strand-specific RNA sequencing, mass spectrometry-based proteomics, and multiplex immunofluorescence/immunohistochemistry. Clinical data will be collected retrospectively from medical records. The study aims to characterize the multi-omics landscape, establish molecular subtypes, and develop prognostic prediction models. Receives: Other: Multi-omics profiling of archived tumor tissue (observational) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic Alteration Landscape
Somatic mutations (SNV/Indel), copy number variations (CNV), structural variations (SV), mutational signatures, clonal architecture, tumor mutational burden (TMB), and microsatellite instability (MSI) status, assessed by whole-exome sequencing or large-panel targeted sequencing of archived tumor tissue.
Measured: At the time of archived tumor tissue specimen collection (at surgery or biopsy; specific date based on pathology records).
Transcriptomic Expression Profile
Differentially expressed genes, fusion genes, and gene set enrichment (GSEA) analyzed by strand-specific RNA sequencing (RNA-seq) of archived tumor tissue.
Measured: At the time of archived tumor tissue specimen collection (at surgery or biopsy; specific date based on pathology records).
Secondary outcomes (2)
Progression-Free Survival (PFS)
Time from treatment initiation to first documented disease progression (per RECIST 1.1 by imaging) or death from any cause, whichever occurs first.
Measured: From the date of treatment initiation to the date of first documented progression or death from any cause, whichever occurs first; assessed up to 132 months.
Overall Survival (OS)
Time from treatment initiation to death from any cause.
Measured: From the date of treatment initiation to the date of death from any cause; assessed up to 132 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Neuroendocrine CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Li, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879339
- Sponsor's protocol ID
- K11933
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Retrospective Multi-Omics Study of Cervical Neuroendocrine Carcinoma
- ClinicalTrials.gov ID
- NCT07879339
- Acronym / sponsor ID
- K11933
- Conditions
- Cervical Neuroendocrine Carcinoma
- Keywords
- Neuroendocrine Carcinoma of Cervix, Multi-omics study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 Oct 2026 (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.
This is a retrospective study using archived tumor tissue and medical records from patients with cervical neuroendocrine carcinoma treated at Peking Union Medical College Hospital since January 1, 2015. Cervical neuroendocrine carcinoma is a rare and highly aggressive cervical cancer with no standard treatment. The study will analyze the tumor's genes, RNA, proteins, and immune environment to better understand its molecular features, identify molecular subtypes, find markers related to survival and immunotherapy, and build a prognostic prediction model. No new patients will be enrolled, and no additional tests or treatments will be given. About 80-120 patients are expected to be included. Results may help improve future diagnosis and personalized treatment for this rare cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NECC Multi-Omics Retrospective Cohort | – | Other: Multi-omics profiling of archived tumor tissue (observational)This is a single-center, retrospective cohort of approximately 80-120 patients with histologically confirmed cervical neuroendocrine carcinoma (NECC) treated at Peking Union Medical College Hospital since January 1, 2015. Eligible patients have archived tumor tissue (FFPE or fresh-frozen) and complete retrospective clinical follow-up data. No intervention is administered as part of this study. Archived specimens will undergo multi-omics testing, including whole-exome sequencing or large-panel targeted sequencing, strand-specific RNA sequencing, mass spectrometry-based proteomics, and multiplex immunofluorescence/immunohistochemistry. Clinical data will be collected retrospectively from medical records. The study aims to characterize the multi-omics landscape, establish molecular subtypes, and develop prognostic prediction models. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study population comprises approximately 80-120 adult female patients (aged ≥18 years) with histologically confirmed cervical neuroendocrine carcinoma (NECC), including small cell, large cell, and mixed types, who were treated at Peking Union Medical College Hospital between January 1, 2015 and the present. Eligible patients have archived tumor tissue specimens (formalin-fixed paraffin-embedded or fresh-frozen) available for multi-omics testing and complete retrospective clinical data, including baseline characteristics, treatment information, efficacy and survival outcomes, and follow-up records. Patients with inadequate specimen quality for multi-omics testing, severely missing key clinical data, or concomitant other malignancies (excluding non-melanoma skin cancer) will be excluded.
Key inclusion criteria (4 listed)
- 1: Inclusion criteria Age ≥ 18 years
- 2: Histopathologically confirmed neuroendocrine carcinoma of the cervix (including small cell type, large cell type, and mixed type), reviewed and confirmed by at least two pathologists
- 3: Sufficient quality and quantity of archived tumor tissue specimens available for multi-omics testing (formalin-fixed paraffin-embedded tissue sections ≥ 10 slides or fresh frozen tissue ≥ 50 mg)
- 4: Complete clinical medical records and follow-up data (including at least diagnostic information, treatment regimen, and survival follow-up)
Key exclusion criteria (4 listed)
- 1: Failure to meet all of the above inclusion criteria
- 2: Archived tumor tissue specimens of inadequate quality for multi-omics testing
- 3: Severely missing key clinical data that preclude the extraction of valid information
- 4: Concomitant other malignancies (excluding non-melanoma skin cancer)
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 |
|---|---|---|
| Multi-omics profiling of archived tumor tissue (observational)This is a retrospective, observational multi-omics study. No therapeutic intervention (drug, device, procedure, or behavioral modification) is administered to patients. The "intervention" in this context refers solely to the molecular profiling performed on archived tumor tissue specimens and the retrospective collection of clinical data. The multi-omics profiling includes whole-exome sequencing (WES) or large-panel targeted sequencing, strand-specific RNA sequencing, mass spectrometry-based proteomics, and multiplex immunofluorescence/immunohistochemistry (mIF/IHC). These assays are designed to comprehensively characterize the genomic, transcriptomic, proteomic, and tumor immune microenvironment landscape of cervical neuroendocrine carcinoma (NECC). This distinguishes the present study from others by its integrated multi-omics approach and focus on molecular subtyping, rather than evaluating a specific therapeutic agent. | Other | NECC Multi-Omics Retrospective Cohort |
Primary outcome
Genomic Alteration Landscape
Time frame: At the time of archived tumor tissue specimen collection (at surgery or biopsy; specific date based on pathology records).
Somatic mutations (SNV/Indel), copy number variations (CNV), structural variations (SV), mutational signatures, clonal architecture, tumor mutational burden (TMB), and microsatellite instability (MSI) status, assessed by whole-exome sequencing or large-panel targeted sequencing of archived tumor tissue.
Transcriptomic Expression Profile
Time frame: At the time of archived tumor tissue specimen collection (at surgery or biopsy; specific date based on pathology records).
Differentially expressed genes, fusion genes, and gene set enrichment (GSEA) analyzed by strand-specific RNA sequencing (RNA-seq) of archived tumor tissue.
2 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From the date of treatment initiation to the date of first documented progression or death from any cause, whichever occurs first; assessed up to 132 months.
Overall Survival (OS)
Time frame: From the date of treatment initiation to the date of death from any cause; assessed up to 132 months.
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 16 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Neuroendocrine Carcinoma, run by Peking Union Medical College Hospital at 1 site 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 4 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: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 Lei Li (86-139-1198-8831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genomic Alteration Landscape (time frame: At the time of archived tumor tissue specimen collection (at surgery or biopsy; specific date based on pathology records).). 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 16 Oct 2026.