CancerNCT00984035
Investigation of Cisplatin-Related Kidney Toxicity
An observational study of Cancer, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to identify novel biomarkers of kidney injury in patients receiving cisplatin. This study will also collect DNA for future analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- urine samples (biomarkers), blood samples (biomarkers) and blood sample (DNA)
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2009to Mar 2018
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving anti-cancer treatment with cisplatin (or previously treated with cisplatin) at a participating academic medical center.
Who may be able to join
- Patients about to receive intravenous cisplatin for the first time as part of cancer chemotherapy.
- Aged 18 years and older.
- Ability to understand and willingness to sign a written consent document.
- Patients may be receiving cisplatin in combination with other chemotherapeutic agents.
- Patients may be receiving cisplatin in the context of another clinical trial.
- Patients that have previously received intravenous cisplatin as part of cancer chemotherapy.
Show all 10Show fewer
- Aged 18 years and older.
- Ability to understand and willingness to sign a written consent document.
- Patients that received cisplatin in combination with other chemotherapeutic agents are eligible.
- Patients that received cisplatin in the context of a clinical trial are eligible.
Who cannot join
- Prior receipt of cisplatin.
- Patients on dialysis or other renal replacement therapy prior to starting cisplatin.
- Uncontrolled hypo- or hyperthyroidism (patients on chronic stable doses of thyroid replacement medication are eligible).
- Retrospective Analysis Group
- Unable or unwilling to submit to a one-time blood draw.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Germline Genetic Determinants and Early Biomarkers of Cisplatin-Related Nephrotoxicity
The purpose of this study is to identify novel biomarkers of kidney injury in patients receiving cisplatin.
This study will also collect DNA for future analysis.
Read the detailed description
This study will look for novel biomarkers of kidney injury in patients receiving cisplatin in patients currently receiving cisplatin.
DNA will be collected both prospectively and retrospectively (from patients that have previously received cisplatin.
- Conditions
- Cancer
- Being tested
- urine samples (biomarkers), blood samples (biomarkers), blood sample (DNA)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine samples (biomarkers)Other
Urine samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose.
blood samples (biomarkers)Other
blood samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose.
blood sample (DNA)Other
Blood sample collected for DNA analysis at anytime while on-study.
| Study group | Role | What they receive |
|---|---|---|
| Prospecitive Analysis | Patients currently receiving cisplatin as treatment for their cancer. Receives: Other: urine samples (biomarkers); Other: blood samples (biomarkers); Other: blood sample (DNA) | |
| Restrospective Analysis | Patients that have previously received cisplatin as treatment for their cancer. Receives: Other: blood sample (DNA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urine biomarker (NGAL) after cisplatin
Measured: while on drug and up to 35 days after end of treatment
Secondary outcomes (3)
Change in blood and urine cystatin C
Measured: while on drug and up to 35 days after end of treatment
Change in blood NGAL while receiving cisplatin
Measured: while on drug and up to 35 days after end of treatment
Genetic markers of kidney toxicity
Measured: while on drug and up to 35 days after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2009 (estimated)
- Study start22 Sep 2009
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Clinical Oncology, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Peter H O'Donnell, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984035
- Sponsor's protocol ID
- 09-135-B
- Status last verified
- Sep 2018
- First submitted
- 22 Sep 2009
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Germline Genetic Determinants and Early Biomarkers of Cisplatin-Related Nephrotoxicity
- ClinicalTrials.gov ID
- NCT00984035
- Acronym / sponsor ID
- 09-135-B
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- American Society of Clinical Oncology, National Institutes of Health (NIH)
- Study start
- 22 Sep 2009 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 24 Sep 2009 (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 purpose of this study is to identify novel biomarkers of kidney injury in patients receiving cisplatin.
This study will also collect DNA for future analysis.
Detailed description
This study will look for novel biomarkers of kidney injury in patients receiving cisplatin in patients currently receiving cisplatin.
DNA will be collected both prospectively and retrospectively (from patients that have previously received cisplatin.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospecitive Analysis | – | Other: urine samples (biomarkers), Other: blood samples (biomarkers), Other: blood sample (DNA)Patients currently receiving cisplatin as treatment for their cancer. |
| Restrospective Analysis | – | Other: blood sample (DNA)Patients that have previously received cisplatin as treatment for their cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving anti-cancer treatment with cisplatin (or previously treated with cisplatin) at a participating academic medical center.
Key inclusion criteria (10 listed)
- Patients about to receive intravenous cisplatin for the first time as part of cancer chemotherapy.
- Aged 18 years and older.
- Ability to understand and willingness to sign a written consent document.
- Patients may be receiving cisplatin in combination with other chemotherapeutic agents.
- Patients may be receiving cisplatin in the context of another clinical trial.
Key exclusion criteria (5 listed)
- Prior receipt of cisplatin.
- Patients on dialysis or other renal replacement therapy prior to starting cisplatin.
- Uncontrolled hypo- or hyperthyroidism (patients on chronic stable doses of thyroid replacement medication are eligible).
- Retrospective Analysis Group
- Unable or unwilling to submit to a one-time blood draw.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urine samples (biomarkers)Urine samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose. | Other | Prospecitive Analysis |
| blood samples (biomarkers)blood samples collected prior to first dose of cisplatin, after each dose of cisplatin, and within 35 days of the last dose. | Other | Prospecitive Analysis |
| blood sample (DNA)Blood sample collected for DNA analysis at anytime while on-study. | Other | Prospecitive Analysis, Restrospective Analysis |
Primary outcome
Change in urine biomarker (NGAL) after cisplatin
Time frame: while on drug and up to 35 days after end of treatment
3 secondary outcomes
Change in blood and urine cystatin C
Time frame: while on drug and up to 35 days after end of treatment
Change in blood NGAL while receiving cisplatin
Time frame: while on drug and up to 35 days after end of treatment
Genetic markers of kidney toxicity
Time frame: while on drug and up to 35 days after end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Peter H O'Donnell, MD principal investigator
University of Chicago
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 Cancer, run by University of Chicago 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 10 inclusion and 5 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: finished, as of the sponsor's last update on 11 Sep 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in urine biomarker (NGAL) after cisplatin (time frame: while on drug and up to 35 days after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2018.