Ovarian NeoplasmsNCT02478476
DNA Single Nucleotide Polymorphisms as Predictors of Toxicity
An observational study of Ovarian Neoplasms and Fallopian Tube Neoplasms, run by OvaGene Oncology, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pathologically confirmed ovarian, fallopian tube, or peritoneal cancer scheduled to receive platinum and/or taxane based chemotherapy.
Who may be able to join
- Female, greater than or equal to 18 years of age.
- Must have pathologically confirmed ovarian, fallopian tube, or primary peritoneal cancer.
- Able to provide a blood sample (3-5ml).
- Planned course of therapy includes a platinum and/or taxane based chemotherapy.
Who cannot join
- Has a clinically significant (per judgment of the PI) neurodegenerative, hematological, or cardiac related disease.
- Has received prior chemotherapy.
- Unable or unwilling to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Robert W Holloway, MD contact
United States1 site
Florida Hospital Cancer Institute
Orlando, Florida, 32804
Robert W Holloway, MD, 407-303-2422
About this study
Official title: DNA Single Nucleotide Polymorphisms as Predictors of Platinum and Taxane Related Adverse Events in Ovarian, Fallopian Tube, and Peritoneal Cancer Patients
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.
Read the detailed description
The majority of ovarian cancer patients are treated with a combination of platinum- and taxane-based chemotherapy. While initial response rates are high (>90%), some patients experience severe AEs which can lead to discontinuation of therapy. However, both GOG and the paclitaxel package insert include treatment guidelines that involve a decreased dose regimen if AEs are encountered [1, 2]. The clinical validation of the genetic differences in these genes as biomarkers for severe AEs would allow the treating physician to alter dosing, thus increasing the time a patient could remain on the drug while decreasing side effects and unnecessary morbidity.
Another clinical utility of these genetic differences in ovarian cancer patient care is in the identification of which patients may not benefit from intraperitoneal (IP) chemotherapy or dose dense chemotherapy. While IP chemotherapy has been shown to improve patient outcome, the side effects are much more frequent and severe due to the high dose [3]. Testing the patients prior to treatment for predictive genotypes may factor into a doctor's decision to forego IP chemotherapy in favor of standard intravenous delivery. Dose dense chemotherapy has demonstrated improvements in outcome but also some increases in side effects [4, 5]. In both therapy regimens, the ability to stratify patients based on the risks of toxicities associated with treatment may lead to a greater benefit of IP or dose dense therapy while minimizing side effects and associated health care costs.
Previous studies in ovarian cancer have demonstrated that expression of the proteins ERCC1, GST, and p53 can affect the response to platinum based therapies in ovarian cancer patients [6-13]. When SNPs in the genes that encode these proteins were evaluated, a correlation to AEs in response to platinum-based therapies was made [14, 15]. Mutations that affected activity of ERCC1 were associated with nephrotoxicity. Mutations in GST family members were associated with neutropenia (GSTA1), neuropathy (GSTM3 and GSTP1), or anemia and thrombocytopenia (GSTM3). Mutations in p53 were associated with neutropenia. In these studies, mutations in XPD and XRCC1 were also found to be predictive of neutropenia (both XPD and XRCC1) and anemia (XPD only). More recently, a study done by the Scottish Gynecological Clinical Trials Group identified SNPs in BCL2, Current Version Date: 04/01/15 Previous Version Date: N/A, Initial version Page 6 of 23 OPRM1 SOX10 and TRPV1 that were associated with neurotoxicity [16]. Both the individual and combined value of these biomarkers needs to be assessed.
Reviewing studies done in other tumor types has identified SNPs associated with toxicities that may also be applicable in ovarian cancer. In breast cancer, SNPs in the CYP2C8, CYP17A1, and ABCG1 genes have been associated with an increased risk of grade 2+ peripheral neuropathy in patients treated with taxane-based therapies. [17, 18]. A different SNP in CYP17A1 (rs619824) has also been previously reported to be associated with bortezomib-induced neuropathy in multiple myeloma patients, potentially supporting the role of this protein in the onset of neuropathy [19]. Since these SNPs are germ line differences, there is reason to believe they may be valuable biomarkers in ovarian cancer also. In multiple myeloma, it has been suggested that identification and closer monitoring of patients at risk for neuropathy could be beneficial [20]. A similar strategy could be used with ovarian cancer patients to reduce severe toxicities that results in discontinuation of an effective drug.
The detection of these polymorphisms by QPCR has been confirmed by direct sequencing of cell lines and tumor tissue. The protocol has been tested in our research lab and has been validated in our CLIA regulated lab for both formalin fixed paraffin embedded samples and blood. In brief, DNA is purified over a spin column, quantitated, and mixed with a specific SNP assay and Master Mix (Life Technologies). Results were analyzed in the Life Technologies TaqMan Genotyper software version 1.3 to determine genotype. The SNPs were detected in blood samples collected from ovarian cancer patients and FFPE ovarian cancer specimens with similar frequencies as reported in the papers referenced above. SNPs from other tumor types were detected in the same blood samples from ovarian cancer patients or FFPE ovarian cancer specimens as well as in blood and FFPE samples from endometrial cancer patients.
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of chemotherapy related toxicities including Anemia, Nephrotoxicity, Neutropenia, Neuropathy, and Thrombocytopenia associated with genotype.
Specific genotypes will be evaluated as predictors of toxicity when patients receive platinum and/or taxane based chemotherapy.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OvaGene Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Ricketts, PhD, Study director, OvaGene Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478476
- Sponsor's protocol ID
- IRBNet#673096
- Status last verified
- Jun 2015
- First submitted
- 16 Jun 2015
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Paclitaxel, [package insert], Bristol-Meyers Squibb Company, Princeton, NJ, April 2011.
Chemotherapy procedure Manual, Gynecologic Oncology Group, January 2004.
Wenzel 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.
PubMed 17264340Katsumata 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.
PubMed 19767092Glaze 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.
PubMed 23343799Milovic-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.
PubMed 22331726Scheil-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.
PubMed 20728204Steffensen KD, Waldstrom M, Jakobsen A. The relationship of platinum resistance and ERCC1 protein expression in epithelial ovarian cancer. Int J Gynecol Cancer. 2009 Jul;19(5):820-5. doi: 10.1111/IGC.0b013e3181a12e09.
PubMed 19574766Steffensen KD, Waldstrom M, Jeppesen U, Brandslund I, Jakobsen A. Prediction of response to chemotherapy by ERCC1 immunohistochemistry and ERCC1 polymorphism in ovarian cancer. Int J Gynecol Cancer. 2008 Jul-Aug;18(4):702-10. doi: 10.1111/j.1525-1438.2007.01068.x. Epub 2007 Oct 24.
PubMed 17961161Hirazono K, Shinozuka T, Kuroshima Y, Itoh H, Kawai K. Immunohistochemical expression of glutathione S-transferase pi (GST-pi) and chemotherapy response in malignant ovarian tumors. J Obstet Gynaecol (Tokyo 1995). 1995 Jun;21(3):305-12. doi: 10.1111/j.1447-0756.1995.tb01015.x.
PubMed 8590371Howells RE, Dhar KK, Hoban PR, Jones PW, Fryer AA, Redman CW, Strange RC. Association between glutathione-S-transferase GSTP1 genotypes, GSTP1 over-expression, and outcome in epithelial ovarian cancer. Int J Gynecol Cancer. 2004 Mar-Apr;14(2):242-50. doi: 10.1111/j.1048-891X.2004.014207.x.
PubMed 15086723Bali A, O'Brien PM, Edwards LS, Sutherland RL, Hacker NF, Henshall SM. Cyclin D1, p53, and p21Waf1/Cip1 expression is predictive of poor clinical outcome in serous epithelial ovarian cancer. Clin Cancer Res. 2004 Aug 1;10(15):5168-77. doi: 10.1158/1078-0432.CCR-03-0751.
PubMed 15297421Ferrandina G, Fagotti A, Salerno MG, Natali PG, Mottolese M, Maneschi F, De Pasqua A, Benedetti-Panici P, Mancuso S, Scambia G. p53 overexpression is associated with cytoreduction and response to chemotherapy in ovarian cancer. Br J Cancer. 1999 Oct;81(4):733-40. doi: 10.1038/sj.bjc.6690756.
PubMed 10574264Khrunin AV, Moisseev A, Gorbunova V, Limborska S. Genetic polymorphisms and the efficacy and toxicity of cisplatin-based chemotherapy in ovarian cancer patients. Pharmacogenomics J. 2010 Feb;10(1):54-61. doi: 10.1038/tpj.2009.45. Epub 2009 Sep 29.
PubMed 19786980Sakano S, Hinoda Y, Sasaki M, Wada T, Matsumoto H, Eguchi S, Shinohara A, Kawai Y, Hara T, Nagao K, Hara T, Naito K, Matsuyama H. Nucleotide excision repair gene polymorphisms may predict acute toxicity in patients treated with chemoradiotherapy for bladder cancer. Pharmacogenomics. 2010 Oct;11(10):1377-87. doi: 10.2217/pgs.10.106.
PubMed 21047201
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Single Nucleotide Polymorphisms as Predictors of Platinum and Taxane Related Adverse Events in Ovarian, Fallopian Tube, and Peritoneal Cancer Patients
- ClinicalTrials.gov ID
- NCT02478476
- Acronym / sponsor ID
- IRBNet#673096
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- OvaGene Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 23 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The majority of ovarian cancer patients are treated with a combination of platinum- and taxane-based chemotherapy. While initial response rates are high (>90%), some patients experience severe AEs which can lead to discontinuation of therapy. However, both GOG and the paclitaxel package insert include treatment guidelines that involve a decreased dose regimen if AEs are encountered [1, 2]. The clinical validation of the genetic differences in these genes as biomarkers for severe AEs would allow the treating physician to alter dosing, thus increasing the time a patient could remain on the drug while decreasing side effects and unnecessary morbidity.
Another clinical utility of these genetic differences in ovarian cancer patient care is in the identification of which patients may not benefit from intraperitoneal (IP) chemotherapy or dose dense chemotherapy. While IP chemotherapy has been shown to improve patient outcome, the side effects are much more frequent and severe due to the high dose [3]. Testing the patients prior to treatment for predictive genotypes may factor into a doctor's decision to forego IP chemotherapy in favor of standard intravenous delivery. Dose dense chemotherapy has demonstrated improvements in outcome but also some increases in side effects [4, 5]. In both therapy regimens, the ability to stratify patients based on the risks of toxicities associated with treatment may lead to a greater benefit of IP or dose dense therapy while minimizing side effects and associated health care costs.
Previous studies in ovarian cancer have demonstrated that expression of the proteins ERCC1, GST, and p53 can affect the response to platinum based therapies in ovarian cancer patients [6-13]. When SNPs in the genes that encode these proteins were evaluated, a correlation to AEs in response to platinum-based therapies was made [14, 15]. Mutations that affected activity of ERCC1 were associated with nephrotoxicity. Mutations in GST family members were associated with neutropenia (GSTA1), neuropathy (GSTM3 and GSTP1), or anemia and thrombocytopenia (GSTM3). Mutations in p53 were associated with neutropenia. In these studies, mutations in XPD and XRCC1 were also found to be predictive of neutropenia (both XPD and XRCC1) and anemia (XPD only). More recently, a study done by the Scottish Gynecological Clinical Trials Group identified SNPs in BCL2, Current Version Date: 04/01/15 Previous Version Date: N/A, Initial version Page 6 of 23 OPRM1 SOX10 and TRPV1 that were associated with neurotoxicity [16]. Both the individual and combined value of these biomarkers needs to be assessed.
Reviewing studies done in other tumor types has identified SNPs associated with toxicities that may also be applicable in ovarian cancer. In breast cancer, SNPs in the CYP2C8, CYP17A1, and ABCG1 genes have been associated with an increased risk of grade 2+ peripheral neuropathy in patients treated with taxane-based therapies. [17, 18]. A different SNP in CYP17A1 (rs619824) has also been previously reported to be associated with bortezomib-induced neuropathy in multiple myeloma patients, potentially supporting the role of this protein in the onset of neuropathy [19]. Since these SNPs are germ line differences, there is reason to believe they may be valuable biomarkers in ovarian cancer also. In multiple myeloma, it has been suggested that identification and closer monitoring of patients at risk for neuropathy could be beneficial [20]. A similar strategy could be used with ovarian cancer patients to reduce severe toxicities that results in discontinuation of an effective drug.
The detection of these polymorphisms by QPCR has been confirmed by direct sequencing of cell lines and tumor tissue. The protocol has been tested in our research lab and has been validated in our CLIA regulated lab for both formalin fixed paraffin embedded samples and blood. In brief, DNA is purified over a spin column, quantitated, and mixed with a specific SNP assay and Master Mix (Life Technologies). Results were analyzed in the Life Technologies TaqMan Genotyper software version 1.3 to determine genotype. The SNPs were detected in blood samples collected from ovarian cancer patients and FFPE ovarian cancer specimens with similar frequencies as reported in the papers referenced above. SNPs from other tumor types were detected in the same blood samples from ovarian cancer patients or FFPE ovarian cancer specimens as well as in blood and FFPE samples from endometrial cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pathologically confirmed ovarian, fallopian tube, or peritoneal cancer scheduled to receive platinum and/or taxane based chemotherapy.
Key inclusion criteria (4 listed)
- Female, greater than or equal to 18 years of age.
- Must have pathologically confirmed ovarian, fallopian tube, or primary peritoneal cancer.
- Able to provide a blood sample (3-5ml).
- Planned course of therapy includes a platinum and/or taxane based chemotherapy.
Key exclusion criteria (3 listed)
- Has a clinically significant (per judgment of the PI) neurodegenerative, hematological, or cardiac related disease.
- Has received prior chemotherapy.
- Unable or unwilling to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of chemotherapy related toxicities including Anemia, Nephrotoxicity, Neutropenia, Neuropathy, and Thrombocytopenia associated with genotype.
Time frame: one year
Specific genotypes will be evaluated as predictors of toxicity when patients receive platinum and/or taxane based chemotherapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
- BackgroundPaclitaxel, [package insert], Bristol-Meyers Squibb Company, Princeton, NJ, April 2011.
- BackgroundChemotherapy procedure Manual, Gynecologic Oncology Group, January 2004.
- Background: PubMed 17264340Wenzel 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.
- Background: PubMed 19767092Katsumata 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.
- Background: PubMed 23343799Glaze 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.
- Background: PubMed 22331726Milovic-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.
- Background: PubMed 20728204Scheil-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.
- Background: PubMed 19574766Steffensen KD, Waldstrom M, Jakobsen A. The relationship of platinum resistance and ERCC1 protein expression in epithelial ovarian cancer. Int J Gynecol Cancer. 2009 Jul;19(5):820-5. doi: 10.1111/IGC.0b013e3181a12e09.
- Background: PubMed 17961161Steffensen KD, Waldstrom M, Jeppesen U, Brandslund I, Jakobsen A. Prediction of response to chemotherapy by ERCC1 immunohistochemistry and ERCC1 polymorphism in ovarian cancer. Int J Gynecol Cancer. 2008 Jul-Aug;18(4):702-10. doi: 10.1111/j.1525-1438.2007.01068.x. Epub 2007 Oct 24.
- Background: PubMed 8590371Hirazono K, Shinozuka T, Kuroshima Y, Itoh H, Kawai K. Immunohistochemical expression of glutathione S-transferase pi (GST-pi) and chemotherapy response in malignant ovarian tumors. J Obstet Gynaecol (Tokyo 1995). 1995 Jun;21(3):305-12. doi: 10.1111/j.1447-0756.1995.tb01015.x.
- Background: PubMed 15086723Howells RE, Dhar KK, Hoban PR, Jones PW, Fryer AA, Redman CW, Strange RC. Association between glutathione-S-transferase GSTP1 genotypes, GSTP1 over-expression, and outcome in epithelial ovarian cancer. Int J Gynecol Cancer. 2004 Mar-Apr;14(2):242-50. doi: 10.1111/j.1048-891X.2004.014207.x.
- Background: PubMed 15297421Bali A, O'Brien PM, Edwards LS, Sutherland RL, Hacker NF, Henshall SM. Cyclin D1, p53, and p21Waf1/Cip1 expression is predictive of poor clinical outcome in serous epithelial ovarian cancer. Clin Cancer Res. 2004 Aug 1;10(15):5168-77. doi: 10.1158/1078-0432.CCR-03-0751.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert W Holloway, MD contact
William Ricketts, PhD study director
OvaGene Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasms and Fallopian Tube Neoplasms, run by OvaGene Oncology, Inc. at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 23 Jun 2015. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert W Holloway, MD ((407)303-2422), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of chemotherapy related toxicities including Anemia, Nephrotoxicity, Neutropenia, Neuropathy, and Thrombocytopenia associated with genotype. (time frame: one year). 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 NCT02478476, which also lists 22 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 23 Jun 2015.