Metastatic Kidney CancerCA9CRMNCT00942058
Serum CA9 Level as Biological Marker of the Treatment Response in Metastatic Renal Cell Cancer
An observational study of Metastatic Kidney Cancer and Metastatic Renal Cell Carcinoma, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
Trial summary
One third of patients with kidney cancer are diagnosed in the metastatic stage, and among patients with a localized form, about 30 to 40% will develop metastases after surgery. Medical treatment of metastatic renal cancer include immunotherapy with interferon α and/or IL-2, or targeted therapies such as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Kidney Cancer, Metastatic Renal Cell Carcinoma
- What is being tested?
- Serum and urinary CA9 level
- How many people
- 16 participants
- Where
- 3 sitesFrance
- Study dates
- Jun 2009to Nov 2013
- 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 with a metastatic conventional renal cell cancer. All patients must sign a consent form to be included in this study.
Who may be able to join
- Conventional renal cell cancer with a pathological diagnosis
- Metastatic disease
- Consent form signed
- social security regimen affiliated
Who cannot join
- Other cancer treated
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Jean Perrin
Clermont-Ferrand, 63011
CHU de Saint-Etienne
Saint-Etienne, 42055
Institut Cancérologique de la Loire
Saint-Priest-en-Jarez, 42270
About this study
Official title: Serum Carbonic Anhydrase 9 (CA9) Level as Biological Marker of the Treatment Response in Metastatic Renal Cell Cancer : a Pilot Study
One third of patients with kidney cancer are diagnosed in the metastatic stage, and among patients with a localized form, about 30 to 40% will develop metastases after surgery.
Medical treatment of metastatic renal cancer include immunotherapy with interferon α and/or IL-2, or targeted therapies such as anti-angiogenic (anti-vascular endothelial growth factor (VEGF), anti-tyrosine kinase inhibitors and m-TOR). These treatments sometimes associated (or IL2 + INF or INF AntiVEGF) do allow for objective response in 15 to 30% of cases (net benefit of targeted therapies), but are carriers of potentially significant side effects and are very expensive. The treatment response is considered on imaging exams repetitive, costly and inconsistently reliable. A serum marker of tumor development would be particularly welcome.
Read more
CA9 is an oncogene also know as CA IX, carbonic anhydrase 9 or MN/CA9. The gene encoding an oncoprotein called indifferently membrane antigen MN, MN/CA9 isoenzyme, carbonic anhydrase IX CA9, G250/MN/CA9 or protein G250. It was demonstrated that the level of expression of CA9 in tumor tissue can be used as a predictive marker of response to immunotherapy.
In previous studies, the investigators tried to use CA9 to improve the differential diagnosis of kidney tumors using tumor biopsy or fine needle aspiration. More recently, the investigators have developed the ELISA and quantitative reat time polymerase chain reaction (RT-PCR) to study the CA9 protein and CA9 mRNA in the serum of patients with non-metastatic kidney cancer. The investigators have thus shown that CA9 was overexpressed prior to surgery and that this expression disappeared after tumor ablation.
Read the detailed description
We propose a pilot study of CA9 serum in patients with adenocarcinoma metastatic cell treated by conventional immunotherapy and / or targeted therapy. This pilot study aims to test the CA9 serum marker of response to medical treatment
- Being tested
- Serum and urinary CA9 level
- Keywords
- biological markers, CA9 protein, metastatic conventional renal cell cancer, kidney cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum and urinary CA9 levelOther
Blood and urinary samples are collected before treatment and at 1, 3, 6, 9 and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| CA9 level | Serum and urinary CA9 level Receives: Other: Serum and urinary CA9 level |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum protein CA9 and mRNA CA9 level under medical treatment
Measured: before treatment, at 1, 3, 6, 9 and 12 months
Secondary outcomes (3)
Correlation clinical response (complete response, partial response, stabilization, progression)-evolution serum CA9 level in blood and urine
Measured: Before treatment, at 1, 3, 6, 9, and 12 months
The type and duration of clinical response based on the initial rate and the slope of decline
Measured: Before treatment, at 1, 3, 6, 9, and 12 months
serum CA9 level basis and during the following treatment groups of the MSKCC prognostic
Measured: Before treatment, at 1, 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Difficult for recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Kidney CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques TOSTAIN, MD-PhD, Study director, CHU de Saint-EtienneNicolas MOTTET, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942058
- Sponsor's protocol ID
- 0808071
- Other IDs
- 2008-A01125-50
- Acronym
- CA9CRM
- Status last verified
- Jan 2014
- First submitted
- 17 Jun 2009
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Li G, Feng G, Gentil-Perret A, Genin C, Tostain J. Serum carbonic anhydrase 9 level is associated with postoperative recurrence of conventional renal cell cancer. J Urol. 2008 Aug;180(2):510-3; discussion 513-4. doi: 10.1016/j.juro.2008.04.024. Epub 2008 Jun 11.
PubMed 18550116
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Carbonic Anhydrase 9 (CA9) Level as Biological Marker of the Treatment Response in Metastatic Renal Cell Cancer : a Pilot Study
- ClinicalTrials.gov ID
- NCT00942058
- Acronym / sponsor ID
- CA9CRM / 0808071
- Keywords
- biological markers, CA9 protein, metastatic conventional renal cell cancer, kidney cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficult for recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 20 Jul 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.
One third of patients with kidney cancer are diagnosed in the metastatic stage, and among patients with a localized form, about 30 to 40% will develop metastases after surgery.
Medical treatment of metastatic renal cancer include immunotherapy with interferon α and/or IL-2, or targeted therapies such as anti-angiogenic (anti-vascular endothelial growth factor (VEGF), anti-tyrosine kinase inhibitors and m-TOR). These treatments sometimes associated (or IL2 + INF or INF AntiVEGF) do allow for objective response in 15 to 30% of cases (net benefit of targeted therapies), but are carriers of potentially significant side effects and are very expensive. The treatment response is considered on imaging exams repetitive, costly and inconsistently reliable. A serum marker of tumor development would be particularly welcome.
CA9 is an oncogene also know as CA IX, carbonic anhydrase 9 or MN/CA9. The gene encoding an oncoprotein called indifferently membrane antigen MN, MN/CA9 isoenzyme, carbonic anhydrase IX CA9, G250/MN/CA9 or protein G250. It was demonstrated that the level of expression of CA9 in tumor tissue can be used as a predictive marker of response to immunotherapy.
In previous studies, the investigators tried to use CA9 to improve the differential diagnosis of kidney tumors using tumor biopsy or fine needle aspiration. More recently, the investigators have developed the ELISA and quantitative reat time polymerase chain reaction (RT-PCR) to study the CA9 protein and CA9 mRNA in the serum of patients with non-metastatic kidney cancer. The investigators have thus shown that CA9 was overexpressed prior to surgery and that this expression disappeared after tumor ablation.
Detailed description
We propose a pilot study of CA9 serum in patients with adenocarcinoma metastatic cell treated by conventional immunotherapy and / or targeted therapy. This pilot study aims to test the CA9 serum marker of response to medical treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CA9 level | – | Other: Serum and urinary CA9 levelSerum and urinary CA9 level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a metastatic conventional renal cell cancer. All patients must sign a consent form to be included in this study.
Key inclusion criteria (4 listed)
- Conventional renal cell cancer with a pathological diagnosis
- Metastatic disease
- Consent form signed
- social security regimen affiliated
Key exclusion criteria (1 listed)
- Other cancer treated
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 |
|---|---|---|
| Serum and urinary CA9 levelBlood and urinary samples are collected before treatment and at 1, 3, 6, 9 and 12 months. | Other | CA9 level |
Primary outcome
serum protein CA9 and mRNA CA9 level under medical treatment
Time frame: before treatment, at 1, 3, 6, 9 and 12 months
3 secondary outcomes
Correlation clinical response (complete response, partial response, stabilization, progression)-evolution serum CA9 level in blood and urine
Time frame: Before treatment, at 1, 3, 6, 9, and 12 months
The type and duration of clinical response based on the initial rate and the slope of decline
Time frame: Before treatment, at 1, 3, 6, 9, and 12 months
serum CA9 level basis and during the following treatment groups of the MSKCC prognostic
Time frame: Before treatment, at 1, 3, 6, 9, and 12 months
Results and safety
The study was stopped early (reason given: Difficult for recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
- Background: PubMed 18550116Li G, Feng G, Gentil-Perret A, Genin C, Tostain J. Serum carbonic anhydrase 9 level is associated with postoperative recurrence of conventional renal cell cancer. J Urol. 2008 Aug;180(2):510-3; discussion 513-4. doi: 10.1016/j.juro.2008.04.024. Epub 2008 Jun 11.
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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.
Jacques TOSTAIN, MD-PhD study director
CHU de Saint-Etienne
Nicolas MOTTET, MD principal investigator
CHU de Saint-Etienne
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Kidney Cancer and Metastatic Renal Cell Carcinoma, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
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 1 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: stopped early, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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 was stopped early (reason given: Difficult for recruiting). Results are not available in the source record.
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?
serum protein CA9 and mRNA CA9 level under medical treatment (time frame: before treatment, at 1, 3, 6, 9 and 12 months). 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 NCT00942058, which also lists 1 linked publication.
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 29 Jan 2014.