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NUT CarcinomaNCT07459127

Multicenter Retrospective Cohort of Pulmonary NUT Carcinoma

An observational study of NUT Carcinoma, run by Three Gorges Hospital of Chongqing University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
NUT Carcinoma
What is being tested?
Standard-of-care anticancer treatment (retrospective)
How many people
150 participants
Where
1 siteChina
Study dates
1 Jan 2023to 1 May 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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 430000

Other trials in China

About this study

Official title: A Multicenter Retrospective Real-World Cohort Study of Pulmonary NUT Carcinoma With Integrated Clinical, Pathologic, and Imaging Analyses

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.

Read the detailed description

This is a multi-center, retrospective observational cohort study of lung NUT carcinoma. Eligible patients diagnosed with lung NUT carcinoma at participating hospitals will be identified based on pathology with supportive evidence of NUT immunohistochemistry (IHC) positivity and/or NUTM1 rearrangement/fusion. Data will be extracted from existing medical records and follow-up documentation, including demographics, tumor characteristics, staging, treatments, and outcomes. When available, routine-care pathology information and imaging data will be collected and de-identified.

Primary outcome: progression-free survival (PFS).

Secondary outcomes: overall survival (OS) and other routinely documented outcomes when available.

No new drugs, devices, procedures, or additional tests will be provided as part of this research. All data will be de-identified and stored with access controls according to applicable regulations and ethics approvals at each participating site.

Conditions
NUT Carcinoma
Being tested
Standard-of-care anticancer treatment (retrospective)
Keywords
NUTM1, Pulmonary NUT carcinoma, Retrospective cohort, Multicenter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From diagnosis through study completion (up to May 2026)

Secondary outcomes (1)

  1. Overall Survival (OS)

    Time from initial diagnosis (index date) to death from any cause.

    Measured: From diagnosis through study completion (up to May 2026)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2026
  2. Study start1 Jan 2023
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 May 2026 (estimated)

Resources

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
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07459127
Sponsor's protocol ID
PNUT-RETRO-01
Other IDs
IRB-2026-9
Status last verified
Mar 2026
First submitted
3 Mar 2026
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22896655

  • 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.

    PubMed 38301600

  • 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.

    PubMed 39900969

  • 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.

    PubMed 32328562

  • 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.

    PubMed 36290813

  • 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.

    PubMed 36219702

  • 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.

    PubMed 34898574

  • 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.

    PubMed 41328494

  • 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.

    PubMed 39862476

  • 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.

    PubMed 40926997

Questions about this trial

What is this clinical trial studying?

An observational study of NUT Carcinoma, run by Three Gorges Hospital of Chongqing University 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 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Mar 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: From diagnosis through study completion (up to May 2026)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07459127, which also lists 10 linked publications.

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 9 Mar 2026.

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