Clinical trial · Observational
DNA Single Nucleotide Polymorphisms as Predictors of Toxicity
DNA Single Nucleotide Polymorphisms as Predictors of Platinum and Taxane Related Adverse Events in Ovarian, Fallopian Tube, and Peritoneal Cancer Patients
- 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 presence of single nucleotide polymorphisms (SNPs) in genes involved in platinum and taxane metabolism and detoxification have been correlated to increased risk of severe adverse events (AEs) when patients receive these drugs. The investigators propose studies to validate a comprehensive panel of twelve SNPs in ovarian cancer patients that may predict AEs when treated with therapies that include platinum and taxanes. Using these results to stratify patients to different dosing regimens, routes of administration, or in recurrent cancer to aid in drug selection, may improve outcome and reduce costs for the management of drug related side effects while not changing standard of care. Since these differences can be detected from blood, the determination of genotypes can be done using a standard blood sample taken after ovarian cancer is confirmed on the patient's pathology report. These genetic differences can be detected by QPCR and Next Generation Sequencing.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Neoplasms | Fallopian Tube Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Peritoneal Neoplasms | Peritoneal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Occurrence of chemotherapy related toxicities including Anemia, Nephrotoxicity, Neutropenia, Neuropathy, and Thrombocytopenia associated with genotype.
- timeFrame
- one year
- description
- Specific genotypes will be evaluated as predictors of toxicity when patients receive platinum and/or taxane based chemotherapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female, greater than or equal to 18 years of age. 2. Must have pathologically confirmed ovarian, fallopian tube, or primary peritoneal cancer. 3. Able to provide a blood sample (3-5ml). 4. Planned course of therapy includes a platinum and/or taxane based chemotherapy. Exclusion Criteria: 1. Has a clinically significant (per judgment of the PI) neurodegenerative, hematological, or cardiac related disease. 2. Has received prior chemotherapy. 3. Unable or unwilling to provide informed consent.
References
Publications (22)
- BACKGROUNDPaclitaxel, [package insert], Bristol-Meyers Squibb Company, Princeton, NJ, April 2011.
- BACKGROUNDChemotherapy procedure Manual, Gynecologic Oncology Group, January 2004.
- BACKGROUNDWenzel LB, Huang HQ, Armstrong DK, Walker JL, Cella D; Gynecologic Oncology Group. Health-related quality of life during and after intraperitoneal versus intravenous chemotherapy for optimally debulked ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Feb 1;25(4):437-43. doi: 10.1200/JCO.2006.07.3494. PMID 17264340
- BACKGROUNDKatsumata N, Yasuda M, Takahashi F, Isonishi S, Jobo T, Aoki D, Tsuda H, Sugiyama T, Kodama S, Kimura E, Ochiai K, Noda K; Japanese Gynecologic Oncology Group. Dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer: a phase 3, open-label, randomised controlled trial. Lancet. 2009 Oct 17;374(9698):1331-8. doi: 10.1016/S0140-6736(09)61157-0. Epub 2009 Sep 18. PMID 19767092
- BACKGROUNDGlaze S, Teitelbaum L, Chu P, Ghatage P, Nation J, Nelson G. Dose-dense paclitaxel with carboplatin for advanced ovarian cancer: a feasible treatment alternative. J Obstet Gynaecol Can. 2013 Jan;35(1):61-7. doi: 10.1016/s1701-2163(15)31050-1. PMID 23343799
- BACKGROUNDMilovic-Kovacevic M, Srdic-Rajic T, Radulovic S, Bjelogrlic S, Gavrilovic D. Expression of ERCC1 protein in biopsy specimen predicts survival in advanced ovarian cancer patients treated with platinum-based chemotherapy. J BUON. 2011 Oct-Dec;16(4):708-14. PMID 22331726
- BACKGROUNDScheil-Bertram S, Tylus-Schaaf P, du Bois A, Harter P, Oppitz M, Ewald-Riegler N, Fisseler-Eckhoff A. Excision repair cross-complementation group 1 protein overexpression as a predictor of poor survival for high-grade serous ovarian adenocarcinoma. Gynecol Oncol. 2010 Nov;119(2):325-31. doi: 10.1016/j.ygyno.2010.07.018. Epub 2010 Aug 21. PMID 20728204