CarcinomaChemoRenCanNCT01339975
Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma
An observational study of Carcinoma and Carcinoma Renal Cell, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Despite novel treatment options, Renal Cell Carcinoma (RCC) has been characterized by a constant increase in its mortality and consequently requires an important involvement in translational research. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Carcinoma Renal Cell, Kidney Neoplasms
- What is being tested?
- Biological sample
- How many people
- 310 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2011to May 2019
- 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 diagnosed with localized, locally advanced or metastatic Renal Cell Carcinoma
Who may be able to join
- Patients diagnosed with localized, locally advanced or metastatic Renal Cell Carcinoma :
- having a radical or partial nephrectomy
- or treated by RCC-directed targeted therapy
- Patients who have signed and dated an informed consent form with the investigator
Who cannot join
- under 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Despite novel treatment options, Renal Cell Carcinoma (RCC) has been characterized by a constant increase in its mortality and consequently requires an important involvement in translational research.
The aim of this study is to evaluate the interest of CXCL4, CXCL4L1 and CXCR3 as biomarkers in localized, locally advanced or metastatic RCC. Indeed these chemokines have shown anti-angiogenic and anti-tumor properties in experimental models and may be particularly interesting for prognostic and predictive purposes.
Read the detailed description
Based on a physiopathological rationale, the use of RCC-directed antiangiogenic therapies into clinical practice leads to conclusive results and makes RCC a particularly well-suited tumor type to study factors involved in the angiogenic process. Furthermore the intensive use of targeted therapies in clinical practice raised new questions about their management.
Therefore the identification of new molecular biomarkers is important:
- to improve the precision of prognostic models currently based on clinical, biological or histopathological variables
- to identify high risk patients that could benefit from an adjuvant treatment or a closer postoperative follow-up
- to predict the response to antiangiogenic therapies and therefore identify the drug which is likely to be the most effective within an ever increasing pharmacopeia
- to follow the therapy as precisely as possible, predict or attest the disease progression justifying a therapeutic modification
Low CXCL4, CXCL4L1 and CXCR3 tumor expression levels are associated with bad prognosis factors in RCC. Consequently their interest in RCC is worth being evaluated, in two subgroups : Localized / locally advanced renal cell carcinoma and Metastatic renal cell carcinoma.
- Conditions
- Carcinoma, Carcinoma Renal Cell, Kidney Neoplasms, Kidney Diseases, Chemokines
- Being tested
- Biological sample
- Keywords
- Renal Cell Carcinoma, Nephrectomy, Antiangiogenics, Chemokines, Prognostic value, Carcinoma, Carcinoma, Renal Cell, Kidney Neoplasms, Kidney Diseases, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Adenocarcinoma, Urologic Neoplasms, Urogenital Neoplasms, Neoplasms by Site, Urologic Diseases, Adjuvants, Immunologic, Physiological Effects of Drugs, Pharmacologic Actions
- Medical subject headings
- Carcinoma, Carcinoma, Renal Cell, Kidney Neoplasms, Kidney Diseases, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sampleBiological
2 blood samples of 10mL + one urine sample
- on pre-operative d-1/d, post-operative d1 and d5(+/-2),
- one month post-operative,
- at the end of the study in the absence of disease progression or at the date of recurrence or progression if the case arises.
Biological sampleBiological
2 blood samples of 10mL + one urine sample
- before starting the therapy
- at first therapeutic evaluation (2 or 3 months depending on the treatment chosen)
- at the end of the study or at the date of disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Group A. Surgically treated patients | Patients having a radical or partial nephrectomy. Receives: Biological: Biological sample | |
| Group B. Patients treated with targeted therapies | Patients treated by RCC-directed targeted therapy Receives: Biological: Biological sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic value of the markers of interest (CXCL4, CXCL4L1 et CXCR3)
Prognostic value of the markers of interest (CXCL4, CXCL4L1 et CXCR3) will be evaluated by the association of these markers with time to event occurrence.
Localized or locally advanced renal cell carcinoma group:
- local recurrence
- contralateral recurrence
- extra-renal distant recurrence (metastatic progression)
- specific cancer death
- nonspecific cancer death
Metastatic renal cell carcinoma group :
- local recurrence for patients who underwent a nephrectomy
- contralateral reccurence
- metastatic progression
- specific cancer death
- nonspecific cancer death
Measured: 3 years
Secondary outcomes (1)
Predictive value of therapeutic response
Predictive value of therapeutic response will be assessed for patients receiving systemic therapy. It will be evaluated by the association of markers of interest with the therapeutic response.
- RECIST criteria: patients showing a complete response or a partial response, will be considered as "responders"
- The progression of the longest diameter of tumor, the proportion of intra-tumor necrosis (Choi criteria) and +/- the perfusion characteristics of tumor if primitive tumor
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2011 (estimated)
- Study start6 Jun 2011
- Primary completionMay 2014
- Study completionMay 2019
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 CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe BERNHARD, Dr, Principal investigator, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339975
- Sponsor's protocol ID
- CHUBX 2010/45
- Acronym
- ChemoRenCan
- Status last verified
- Aug 2019
- First submitted
- 20 Apr 2011
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Belot A, Grosclaude P, Bossard N, Jougla E, Benhamou E, Delafosse P, Guizard AV, Molinie F, Danzon A, Bara S, Bouvier AM, Tretarre B, Binder-Foucard F, Colonna M, Daubisse L, Hedelin G, Launoy G, Le Stang N, Maynadie M, Monnereau A, Troussard X, Faivre J, Collignon A, Janoray I, Arveux P, Buemi A, Raverdy N, Schvartz C, Bovet M, Cherie-Challine L, Esteve J, Remontet L, Velten M. Cancer incidence and mortality in France over the period 1980-2005. Rev Epidemiol Sante Publique. 2008 Jun;56(3):159-175. doi: 10.1016/j.respe.2008.03.117. Epub 2008 Jun 10.
PubMed 18547762Raynal G, Bernhard JC. [Premature death from urologic cancer: the kidneys at the forefront]. Prog Urol. 2007 Apr;17(2):260-1. doi: 10.1016/s1166-7087(07)92277-0. No abstract available. French.
PubMed 17489332Motzer RJ, Mazumdar M, Bacik J, Berg W, Amsterdam A, Ferrara J. Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J Clin Oncol. 1999 Aug;17(8):2530-40. doi: 10.1200/JCO.1999.17.8.2530.
PubMed 10561319Margulis V, Sanchez-Ortiz RF, Tamboli P, Cohen DD, Swanson DA, Wood CG. Renal cell carcinoma clinically involving adjacent organs: experience with aggressive surgical management. Cancer. 2007 May 15;109(10):2025-30. doi: 10.1002/cncr.22629.
PubMed 17420980Mickisch GH, Garin A, van Poppel H, de Prijck L, Sylvester R; European Organisation for Research and Treatment of Cancer (EORTC) Genitourinary Group. Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial. Lancet. 2001 Sep 22;358(9286):966-70. doi: 10.1016/s0140-6736(01)06103-7.
PubMed 11583750Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):115-24. doi: 10.1056/NEJMoa065044.
PubMed 17215529Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34. doi: 10.1056/NEJMoa060655.
PubMed 17215530Escudier B, Pluzanska A, Koralewski P, Ravaud A, Bracarda S, Szczylik C, Chevreau C, Filipek M, Melichar B, Bajetta E, Gorbunova V, Bay JO, Bodrogi I, Jagiello-Gruszfeld A, Moore N; AVOREN Trial investigators. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet. 2007 Dec 22;370(9605):2103-11. doi: 10.1016/S0140-6736(07)61904-7.
PubMed 18156031Ravaud A, Wallerand H, Culine S, Bernhard JC, Fergelot P, Bensalah K, Patard JJ. Update on the medical treatment of metastatic renal cell carcinoma. Eur Urol. 2008 Aug;54(2):315-25. doi: 10.1016/j.eururo.2008.04.056. Epub 2008 May 5.
PubMed 18485581Maione TE, Gray GS, Petro J, Hunt AJ, Donner AL, Bauer SI, Carson HF, Sharpe RJ. Inhibition of angiogenesis by recombinant human platelet factor-4 and related peptides. Science. 1990 Jan 5;247(4938):77-9. doi: 10.1126/science.1688470.
PubMed 1688470Jouan V, Canron X, Alemany M, Caen JP, Quentin G, Plouet J, Bikfalvi A. Inhibition of in vitro angiogenesis by platelet factor-4-derived peptides and mechanism of action. Blood. 1999 Aug 1;94(3):984-93.
PubMed 10419890Lasagni L, Francalanci M, Annunziato F, Lazzeri E, Giannini S, Cosmi L, Sagrinati C, Mazzinghi B, Orlando C, Maggi E, Marra F, Romagnani S, Serio M, Romagnani P. An alternatively spliced variant of CXCR3 mediates the inhibition of endothelial cell growth induced by IP-10, Mig, and I-TAC, and acts as functional receptor for platelet factor 4. J Exp Med. 2003 Jun 2;197(11):1537-49. doi: 10.1084/jem.20021897.
PubMed 12782716Eisman R, Surrey S, Ramachandran B, Schwartz E, Poncz M. Structural and functional comparison of the genes for human platelet factor 4 and PF4alt. Blood. 1990 Jul 15;76(2):336-44.
PubMed 1695112Struyf S, Burdick MD, Proost P, Van Damme J, Strieter RM. Platelets release CXCL4L1, a nonallelic variant of the chemokine platelet factor-4/CXCL4 and potent inhibitor of angiogenesis. Circ Res. 2004 Oct 29;95(9):855-7. doi: 10.1161/01.RES.0000146674.38319.07. Epub 2004 Sep 30.
PubMed 15459074Struyf S, Burdick MD, Peeters E, Van den Broeck K, Dillen C, Proost P, Van Damme J, Strieter RM. Platelet factor-4 variant chemokine CXCL4L1 inhibits melanoma and lung carcinoma growth and metastasis by preventing angiogenesis. Cancer Res. 2007 Jun 15;67(12):5940-8. doi: 10.1158/0008-5472.CAN-06-4682.
PubMed 17575164
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01339975
- Acronym / sponsor ID
- ChemoRenCan / CHUBX 2010/45
- Conditions
- Carcinoma, Carcinoma Renal Cell, Kidney Neoplasms, Kidney Diseases, Chemokines
- Keywords
- Renal Cell Carcinoma, Nephrectomy, Antiangiogenics, Chemokines, Prognostic value, Carcinoma, Carcinoma, Renal Cell, Kidney Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 6 Jun 2011 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 21 Apr 2011 (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.
Despite novel treatment options, Renal Cell Carcinoma (RCC) has been characterized by a constant increase in its mortality and consequently requires an important involvement in translational research.
The aim of this study is to evaluate the interest of CXCL4, CXCL4L1 and CXCR3 as biomarkers in localized, locally advanced or metastatic RCC. Indeed these chemokines have shown anti-angiogenic and anti-tumor properties in experimental models and may be particularly interesting for prognostic and predictive purposes.
Detailed description
Based on a physiopathological rationale, the use of RCC-directed antiangiogenic therapies into clinical practice leads to conclusive results and makes RCC a particularly well-suited tumor type to study factors involved in the angiogenic process. Furthermore the intensive use of targeted therapies in clinical practice raised new questions about their management.
Therefore the identification of new molecular biomarkers is important:
- to improve the precision of prognostic models currently based on clinical, biological or histopathological variables
- to identify high risk patients that could benefit from an adjuvant treatment or a closer postoperative follow-up
- to predict the response to antiangiogenic therapies and therefore identify the drug which is likely to be the most effective within an ever increasing pharmacopeia
- to follow the therapy as precisely as possible, predict or attest the disease progression justifying a therapeutic modification
Low CXCL4, CXCL4L1 and CXCR3 tumor expression levels are associated with bad prognosis factors in RCC. Consequently their interest in RCC is worth being evaluated, in two subgroups : Localized / locally advanced renal cell carcinoma and Metastatic renal cell carcinoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A. Surgically treated patients | – | Biological: Biological samplePatients having a radical or partial nephrectomy. |
| Group B. Patients treated with targeted therapies | – | Biological: Biological samplePatients treated by RCC-directed targeted therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with localized, locally advanced or metastatic Renal Cell Carcinoma
Key inclusion criteria (4 listed)
- Patients diagnosed with localized, locally advanced or metastatic Renal Cell Carcinoma :
- Patients who have signed and dated an informed consent form with the investigator
Key exclusion criteria (1 listed)
- under 18 years old
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 |
|---|---|---|
| Biological sample2 blood samples of 10mL + one urine sample * on pre-operative d-1/d, post-operative d1 and d5(+/-2), * one month post-operative, * at the end of the study in the absence of disease progression or at the date of recurrence or progression if the case arises. | Biological | Group A. Surgically treated patients |
| Biological sample2 blood samples of 10mL + one urine sample * before starting the therapy * at first therapeutic evaluation (2 or 3 months depending on the treatment chosen) * at the end of the study or at the date of disease progression. | Biological | Group B. Patients treated with targeted therapies |
Primary outcome
Prognostic value of the markers of interest (CXCL4, CXCL4L1 et CXCR3)
Time frame: 3 years
Prognostic value of the markers of interest (CXCL4, CXCL4L1 et CXCR3) will be evaluated by the association of these markers with time to event occurrence. Localized or locally advanced renal cell carcinoma group: * local recurrence * contralateral recurrence * extra-renal distant recurrence (metastatic progression) * specific cancer death * nonspecific cancer death Metastatic renal cell carcinoma group : * local recurrence for patients who underwent a nephrectomy * contralateral reccurence * metastatic progression * specific cancer death * nonspecific cancer death
1 secondary outcome
Predictive value of therapeutic response
Time frame: 3 years
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 5 Aug 2019.
- Background: PubMed 18547762Belot A, Grosclaude P, Bossard N, Jougla E, Benhamou E, Delafosse P, Guizard AV, Molinie F, Danzon A, Bara S, Bouvier AM, Tretarre B, Binder-Foucard F, Colonna M, Daubisse L, Hedelin G, Launoy G, Le Stang N, Maynadie M, Monnereau A, Troussard X, Faivre J, Collignon A, Janoray I, Arveux P, Buemi A, Raverdy N, Schvartz C, Bovet M, Cherie-Challine L, Esteve J, Remontet L, Velten M. Cancer incidence and mortality in France over the period 1980-2005. Rev Epidemiol Sante Publique. 2008 Jun;56(3):159-175. doi: 10.1016/j.respe.2008.03.117. Epub 2008 Jun 10.
- Background: PubMed 17489332Raynal G, Bernhard JC. [Premature death from urologic cancer: the kidneys at the forefront]. Prog Urol. 2007 Apr;17(2):260-1. doi: 10.1016/s1166-7087(07)92277-0. No abstract available. French.
- Background: PubMed 10561319Motzer RJ, Mazumdar M, Bacik J, Berg W, Amsterdam A, Ferrara J. Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J Clin Oncol. 1999 Aug;17(8):2530-40. doi: 10.1200/JCO.1999.17.8.2530.
- Background: PubMed 17420980Margulis V, Sanchez-Ortiz RF, Tamboli P, Cohen DD, Swanson DA, Wood CG. Renal cell carcinoma clinically involving adjacent organs: experience with aggressive surgical management. Cancer. 2007 May 15;109(10):2025-30. doi: 10.1002/cncr.22629.
- Background: PubMed 11583750Mickisch GH, Garin A, van Poppel H, de Prijck L, Sylvester R; European Organisation for Research and Treatment of Cancer (EORTC) Genitourinary Group. Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial. Lancet. 2001 Sep 22;358(9286):966-70. doi: 10.1016/s0140-6736(01)06103-7.
- Background: PubMed 17215529Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):115-24. doi: 10.1056/NEJMoa065044.
- Background: PubMed 17215530Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34. doi: 10.1056/NEJMoa060655.
- Background: PubMed 18156031Escudier B, Pluzanska A, Koralewski P, Ravaud A, Bracarda S, Szczylik C, Chevreau C, Filipek M, Melichar B, Bajetta E, Gorbunova V, Bay JO, Bodrogi I, Jagiello-Gruszfeld A, Moore N; AVOREN Trial investigators. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet. 2007 Dec 22;370(9605):2103-11. doi: 10.1016/S0140-6736(07)61904-7.
- Background: PubMed 18485581Ravaud A, Wallerand H, Culine S, Bernhard JC, Fergelot P, Bensalah K, Patard JJ. Update on the medical treatment of metastatic renal cell carcinoma. Eur Urol. 2008 Aug;54(2):315-25. doi: 10.1016/j.eururo.2008.04.056. Epub 2008 May 5.
- Background: PubMed 1688470Maione TE, Gray GS, Petro J, Hunt AJ, Donner AL, Bauer SI, Carson HF, Sharpe RJ. Inhibition of angiogenesis by recombinant human platelet factor-4 and related peptides. Science. 1990 Jan 5;247(4938):77-9. doi: 10.1126/science.1688470.
- Background: PubMed 10419890Jouan V, Canron X, Alemany M, Caen JP, Quentin G, Plouet J, Bikfalvi A. Inhibition of in vitro angiogenesis by platelet factor-4-derived peptides and mechanism of action. Blood. 1999 Aug 1;94(3):984-93.
- Background: PubMed 12782716Lasagni L, Francalanci M, Annunziato F, Lazzeri E, Giannini S, Cosmi L, Sagrinati C, Mazzinghi B, Orlando C, Maggi E, Marra F, Romagnani S, Serio M, Romagnani P. An alternatively spliced variant of CXCR3 mediates the inhibition of endothelial cell growth induced by IP-10, Mig, and I-TAC, and acts as functional receptor for platelet factor 4. J Exp Med. 2003 Jun 2;197(11):1537-49. doi: 10.1084/jem.20021897.
- Individual participant dataSharing planned: No
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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.
Jean-Christophe BERNHARD, Dr principal investigator
University Hospital Bordeaux, France
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 Carcinoma and Carcinoma Renal Cell, run by University Hospital, Bordeaux at 1 site 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: finished, as of the sponsor's last update on 5 Aug 2019. 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 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 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?
Prognostic value of the markers of interest (CXCL4, CXCL4L1 et CXCR3) (time frame: 3 years). 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 NCT01339975, 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 5 Aug 2019.