An observational study in Cervical Neuroendocrine Carcinoma, sponsored by Peking Union Medical College Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Peking Union Medical College Hospital · Observational
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.
Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 474 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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)
Exclusion Criteria:
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)
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.
Other: 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.
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.
Time frame: 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.
Time frame: At the time of archived tumor tissue specimen collection (at surgery or biopsy; specific date based on pathology records).
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.
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 from treatment initiation to death from any cause.
Time frame: From the date of treatment initiation to the date of death from any cause; assessed up to 132 months.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2026, 1 month later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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