Clinical trial · Observational
TS Overexpression in SCLC: Mechanism and Therapeutic Targeting
NCT03741829CI-TRIAL-00043218completedClinicalTrials.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)
The purpose of this research study is to determine the amount of a protein named thymidine synthase that is being made by cancer and to develop laboratory models called PDX (patient derived xenografts) to learn more about SCLC (small cell lung cancer) and to begin testing new treatments.
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 |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Samples from transbronchial Biopsy
- description
- Samples from participants with SCLC.
Primary outcomes (2)
- measure
- TYMS (Thymidylate Synthetase) expression levels
- timeFrame
- After biopsy collection, up to 1 year
- description
- TYMS (Thymidylate Synthetase) expression levels will be measured on biopsied malignant tissue as well as non-malignant tissue.
- measure
- miRNA expression levels
- timeFrame
- After biopsy collection, up to 1 year
- description
- miRNA expression levels will be measured on biopsied malignant tissue as well as non-malignant tissue.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing a diagnostic FNA by the following diagnostic modalities utilizing FNA: Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS- TBNA) or conventional transbronchial FNA. * Patients must have radiographic evidence for presumed lung cancer or have a previously diagnosed SCLC with clinical evidence of recurrence. Patients undergoing FNA of potential SCLC metastates to lymph nodes are also included (e.g., patients with abnormal mediastinal lymphadenopathy). FNA biopsies from separate locations in the same patient will be considered separate specimens. * Age \>18 years. Used to define adult age that can independently provide consent. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients whose FNA biopsy is unable to provide classification by pathology or is non-diagnostic.
References
Publications (9)
- BACKGROUNDAsai N, Ohkuni Y, Kaneko N, Yamaguchi E, Kubo A. Relapsed small cell lung cancer: treatment options and latest developments. Ther Adv Med Oncol. 2014 Mar;6(2):69-82. doi: 10.1177/1758834013517413. PMID 24587832
- BACKGROUNDByers LA, Wang J, Nilsson MB, Fujimoto J, Saintigny P, Yordy J, Giri U, Peyton M, Fan YH, Diao L, Masrorpour F, Shen L, Liu W, Duchemann B, Tumula P, Bhardwaj V, Welsh J, Weber S, Glisson BS, Kalhor N, Wistuba II, Girard L, Lippman SM, Mills GB, Coombes KR, Weinstein JN, Minna JD, Heymach JV. Proteomic profiling identifies dysregulated pathways in small cell lung cancer and novel therapeutic targets including PARP1. Cancer Discov. 2012 Sep;2(9):798-811. doi: 10.1158/2159-8290.CD-12-0112. Epub 2012 Sep 6. PMID 22961666
- BACKGROUNDTanaka F, Wada H, Fukui Y, Fukushima M. Thymidylate synthase (TS) gene expression in primary lung cancer patients: a large-scale study in Japanese population. Ann Oncol. 2011 Aug;22(8):1791-7. doi: 10.1093/annonc/mdq730. Epub 2011 Feb 14. PMID 21321092
- BACKGROUNDSocinski MA, Weissman C, Hart LL, Beck JT, Choksi JK, Hanson JP, Prager D, Monberg MJ, Ye Z, Obasaju CK. Randomized phase II trial of pemetrexed combined with either cisplatin or carboplatin in untreated extensive-stage small-cell lung cancer. J Clin Oncol. 2006 Oct 20;24(30):4840-7. doi: 10.1200/JCO.2006.07.7016. PMID 17050869
- BACKGROUNDPardee TS, Gomes E, Jennings-Gee J, Caudell D, Gmeiner WH. Unique dual targeting of thymidylate synthase and topoisomerase1 by FdUMP[10] results in high efficacy against AML and low toxicity. Blood. 2012 Apr 12;119(15):3561-70. doi: 10.1182/blood-2011-06-362442. Epub 2012 Feb 23. PMID 22362039
- BACKGROUNDGmeiner WH, Debinski W, Milligan C, Caudell D, Pardee TS. The applications of the novel polymeric fluoropyrimidine F10 in cancer treatment: current evidence. Future Oncol. 2016 Sep;12(17):2009-20. doi: 10.2217/fon-2016-0091. Epub 2016 Jun 9.