NCT07459127

Brief Summary

This study is a multi-center, retrospective observational study of patients with lung NUT carcinoma. Existing clinical records from participating hospitals will be reviewed to describe patient characteristics, treatments, and outcomes. No study-related interventions will be performed. Data will be de-identified to protect patient privacy.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

3.2 years

First QC Date

March 3, 2026

Last Update Submit

March 6, 2026

Conditions

NUT Carcinoma

Keywords

NUTM1Pulmonary NUT carcinomaRetrospective cohortMulticenter

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival (PFS)

    Time from initial diagnosis (index date) to first documented disease progression per routine clinical assessment or death from any cause, whichever occurs first.

    From diagnosis through study completion (up to May 2026)

Secondary Outcomes (1)

  • Overall Survival (OS)

    From diagnosis through study completion (up to May 2026)

Interventions

Standard-of-care anticancer treatment (retrospective)OTHER

Treatments received as part of routine clinical care and recorded retrospectively in medical records, which may include surgery, radiotherapy, systemic chemotherapy, targeted therapy, and/or immunotherapy. No study-related intervention will be assigned or provided. This observational study only collects and analyzes de-identified real-world treatment and outcome data.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with pulmonary (lung) NUT carcinoma identified retrospectively from participating hospitals using pathology records, with clinical, pathologic, and imaging data abstracted from existing medical records and de-identified for analysis.

You may qualify if:

  • Pathologically confirmed pulmonary (lung) NUT carcinoma.
  • Evidence of NUT immunohistochemistry (IHC) positivity and/or NUTM1 rearrangement/fusion, per local pathology report.
  • Diagnosed and/or treated at a participating hospital during the study period.
  • Availability of sufficient medical record data to abstract key baseline characteristics, treatments, and outcomes.

You may not qualify if:

  • Primary tumor site not in the lung.
  • Records insufficient to confirm the diagnosis of pulmonary NUT carcinoma.
  • No follow-up or outcome information available after diagnosis (insufficient for survival/outcome assessment).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, 430000, China

Location

Related Publications (10)

  • Bauer DE, Mitchell CM, Strait KM, Lathan CS, Stelow EB, Luer SC, Muhammed S, Evans AG, Sholl LM, Rosai J, Giraldi E, Oakley RP, Rodriguez-Galindo C, London WB, Sallan SE, Bradner JE, French CA. Clinicopathologic features and long-term outcomes of NUT midline carcinoma. Clin Cancer Res. 2012 Oct 15;18(20):5773-9. doi: 10.1158/1078-0432.CCR-12-1153. Epub 2012 Aug 15.

    PMID: 22896655BACKGROUND

  • Kloker LD, Sidiras M, Flaadt T, Brecht IB, Deinzer CKW, Gross T, Benzler K, Zender L, Lauer UM. Clinical management of NUT carcinoma (NC) in Germany: Analysis of survival, therapy response, tumor markers and tumor genome sequencing in 35 adult patients. Lung Cancer. 2024 Mar;189:107496. doi: 10.1016/j.lungcan.2024.107496. Epub 2024 Jan 29.

    PMID: 38301600BACKGROUND

  • Luo J, Bishop JA, DuBois SG, Hanna GJ, Sholl LM, Stelow EB, Thompson LDR, Shapiro GI, French CA. Hiding in plain sight: NUT carcinoma is an unrecognized subtype of squamous cell carcinoma of the lungs and head and neck. Nat Rev Clin Oncol. 2025 Apr;22(4):292-306. doi: 10.1038/s41571-025-00986-3. Epub 2025 Feb 3.

    PMID: 39900969BACKGROUND

  • Chau NG, Ma C, Danga K, Al-Sayegh H, Nardi V, Barrette R, Lathan CS, DuBois SG, Haddad RI, Shapiro GI, Sallan SE, Dhar A, Nelson JJ, French CA. An Anatomical Site and Genetic-Based Prognostic Model for Patients With Nuclear Protein in Testis (NUT) Midline Carcinoma: Analysis of 124 Patients. JNCI Cancer Spectr. 2019 Nov 6;4(2):pkz094. doi: 10.1093/jncics/pkz094. eCollection 2020 Apr.

    PMID: 32328562BACKGROUND

  • Yuan J, Xu Z, Guo Y. Diagnosis, Treatment and Prognosis of Primary Pulmonary NUT Carcinoma: A Literature Review. Curr Oncol. 2022 Sep 22;29(10):6807-6815. doi: 10.3390/curroncol29100536.

    PMID: 36290813BACKGROUND

  • Lemelle L, Flaadt T, Fresneau B, Moya-Plana A, Timmermann B, Roganovic J, Ferrari A, Fichera G, Lauer UM, Ben-Ami T, Schneider DT, Vokuhl C, Bolle S, Fox E, DuBois SG, Rodriguez-Galindo C, Bisogno G, Surun A, Brecht IB, Orbach D. NUT Carcinoma in Children and Adolescents: The Expert European Standard Clinical Practice Harmonized Recommendations. J Pediatr Hematol Oncol. 2023 May 1;45(4):165-173. doi: 10.1097/MPH.0000000000002568. Epub 2022 Oct 10.

    PMID: 36219702BACKGROUND

  • Luo W, Stevens TM, Stafford P, Miettinen M, Gatalica Z, Vranic S. NUTM1-Rearranged Neoplasms-A Heterogeneous Group of Primitive Tumors with Expanding Spectrum of Histology and Molecular Alterations-An Updated Review. Curr Oncol. 2021 Nov 7;28(6):4485-4503. doi: 10.3390/curroncol28060381.

    PMID: 34898574BACKGROUND

  • Ye Z, Yan H, Li X, Yang D, Xie F, Deng C, Yin M. Radiotherapy Outcomes and Prognostic Factors in Head and Neck NUT Carcinoma: A Single-Center Cohort Analysis. Head Neck. 2026 Apr;48(4):975-985. doi: 10.1002/hed.70119. Epub 2025 Dec 2.

    PMID: 41328494BACKGROUND

  • Ye Z, Li X, Xie F, Sun J, Yang D, Deng C, Yin M. A single-cell sequencing-based analysis of a 13-year-old with maxillary sinus NUT carcinoma. Oral Oncol. 2025 Mar;162:107185. doi: 10.1016/j.oraloncology.2025.107185. Epub 2025 Jan 24.

    PMID: 39862476BACKGROUND

  • Ye Z, Li X, Zhang M, Xie F, Luo X, Deng C, Yang D, Yin M. Complete Response to BET Inhibitor in Primary Pulmonary NUT Carcinoma With Single-Cell Sequencing-Based Analysis: A Case Report. JTO Clin Res Rep. 2025 Aug 5;6(10):100885. doi: 10.1016/j.jtocrr.2025.100885. eCollection 2025 Oct.

    PMID: 40926997BACKGROUND

MeSH Terms

Interventions

Retrospective Studies

Intervention Hierarchy (Ancestors)

Case-Control StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesCohort StudiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 9, 2026

Study Start

January 1, 2023

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)