Clinical trial · Observational
Multicenter Retrospective Cohort of Pulmonary NUT Carcinoma
A Multicenter Retrospective Real-World Cohort Study of Pulmonary NUT Carcinoma With Integrated Clinical, Pathologic, and Imaging Analyses
NCT07459127CI-TRIAL-00104942active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NUT Carcinoma | NUT Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard-of-care anticancer treatment (retrospective) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- From diagnosis through study completion (up to May 2026)
- description
- Time from initial diagnosis (index date) to first documented disease progression per routine clinical assessment or death from any cause, whichever occurs first.
Secondary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- From diagnosis through study completion (up to May 2026)
- description
- Time from initial diagnosis (index date) to death from any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
References
Publications (10)
- BACKGROUNDBauer 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 22896655
- BACKGROUNDKloker 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 38301600
- BACKGROUNDLuo 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 39900969
- BACKGROUNDChau 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 32328562
- BACKGROUNDYuan 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 36290813
- BACKGROUNDLemelle 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.