CancerONCOCIPNCT02025894
Risk Factors for Thromboembolic and Infectious Complications Related to Percutaneous Central Venous Catheters in Cancer - Prospective Multicenter Study
An observational study of Cancer, run by Institut de Cancérologie de la Loire at 27 sites in France.
Trial summary
The purpose of this study is to identify risk factors for thromboembolic and /or infectious complications in 3,000 patients with solid tumor and receiving a Percutaneous Central Venous Catheter (PCVC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 3,032 participants
- Where
- 27 sitesFrance
- Study dates
- Jun 2010to Mar 2015
- 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: cohort of consecutive patients
Who may be able to join
- Patient with a neoplastic solid tumour with an indication for insertion of a PCVC.
Who cannot join
- Haematological neoplasm pathology, PCVC removal scheduled within 2 weeks of insertion,
- Therapeutic doses of anticoagulants required at inclusion,
- PCVC inserted by the femoral vein
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
France27 sites
CH d'Annecy
Annecy, France
CH Intercommunal Annemasse-Bonneville
Annemasse, France
Polyclinique de Savoie
Annemasse, France
CH Chambéry
Chambéry, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
Pôle Santé république
Clermont-Ferrand, France
CH Feurs
Feurs, France
Institut Daniel Hollard
Grenoble, France
CH EmileRoux
Le Puy-en-Velay, France
CH Lyon Sud
Lyon, France
Clinique de la sauvergarde
Lyon, France
Clinique Eugène André
Lyon, France
Clinique Portes du Sud
Lyon, France
Clinique Saint-Joseph Saint-Luc
Lyon, France
Hôpital de la Croix Rousse
Lyon, France
Hôpital Desgenettes
Lyon, France
Hôpital privé Jean-Mermoz
Lyon, France
Infirmerie Protestante
Lyon, France
CH de Montbrison
Montbrison, France
CH de Roanne
Roanne, France
CH Pays du Gier
Saint-Chamond, France
CHU Saint-Etienne Service de Gynécologie
Saint-Etienne, France, 42055
CHU Saint-Etienne Service de Gastroentérologie
Saint-Etienne, France
Hôpital privé de la Loire
Saint-Etienne, France
Institut Cancérologique Lucien neuwirth
Saint-Priest-en-Jarez, France
Hôpitaux du Léman
Thonon-les-Bains, France
Hôpital Privé Drôme Ardèche
Valence, France
About this study
The purpose of this study is to identify risk factors for thromboembolic and /or infectious complications in 3,000 patients with solid tumor and receiving a Percutaneous Central Venous Catheter (PCVC). A better understanding of the risk factors for these complications in this population would then allow interventional studies to be proposed to assess the benefit of prophylactic procedures in a sub-group of patients at most risk.
- Conditions
- Cancer
- Keywords
- neoplastic solid tumour, PCVC, thromboembolic complications, infectious complications, risk factors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PCVCs | Cohort of cancer patients with indication PCVC under the usual practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thromboembolic complications:
Measured: one year
Locoregional or disseminated infectious complications:
Measured: one year
Secondary outcomes (1)
Medical and economic consequences of these complications
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 posted1 Jan 2014 (estimated)
- Study startJun 2010
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- 3,032 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de la Loire
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Fournel, MD, Principal investigator, Institut Cancérologique Lucien NeuwirthHervé DECOUSUS, MDPhD, Study director, CIC - CHU DE SAINT-ETIENNEFranck CHAUVIN, MDPhD, Study director, Institut cancérologique Lucien Neuwirth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025894
- Sponsor's protocol ID
- 2010-01
- Other IDs
- 2010-A01064-35
- Acronym
- ONCOCIP
- Status last verified
- Dec 2013
- First submitted
- 31 Dec 2013
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Agnelli G, George DJ, Kakkar AK, Fisher W, Lassen MR, Mismetti P, Mouret P, Chaudhari U, Lawson F, Turpie AG; SAVE-ONCO Investigators. Semuloparin for thromboprophylaxis in patients receiving chemotherapy for cancer. N Engl J Med. 2012 Feb 16;366(7):601-9. doi: 10.1056/NEJMoa1108898.
PubMed 22335737Debourdeau P, Farge D, Beckers M, Baglin C, Bauersachs RM, Brenner B, Brilhante D, Falanga A, Gerotzafias GT, Haim N, Kakkar AK, Khorana AA, Lecumberri R, Mandala M, Marty M, Monreal M, Mousa SA, Noble S, Pabinger I, Prandoni P, Prins MH, Qari MH, Streiff MB, Syrigos K, Buller HR, Bounameaux H. International clinical practice guidelines for the treatment and prophylaxis of thrombosis associated with central venous catheters in patients with cancer. J Thromb Haemost. 2013 Jan;11(1):71-80. doi: 10.1111/jth.12071.
PubMed 23217208Saber W, Moua T, Williams EC, Verso M, Agnelli G, Couban S, Young A, De Cicco M, Biffi R, van Rooden CJ, Huisman MV, Fagnani D, Cimminiello C, Moia M, Magagnoli M, Povoski SP, Malak SF, Lee AY. Risk factors for catheter-related thrombosis (CRT) in cancer patients: a patient-level data (IPD) meta-analysis of clinical trials and prospective studies. J Thromb Haemost. 2011 Feb;9(2):312-9. doi: 10.1111/j.1538-7836.2010.04126.x.
PubMed 21040443Akl EA, Kamath G, Yosuico V, Kim SY, Barba M, Sperati F, Cook DJ, Schunemann HJ. Thromboprophylaxis for patients with cancer and central venous catheters: a systematic review and a meta-analysis. Cancer. 2008 Jun;112(11):2483-92. doi: 10.1002/cncr.23479.
PubMed 18404702Mollee P, Jones M, Stackelroth J, van Kuilenburg R, Joubert W, Faoagali J, Looke D, Harper J, Clements A. Catheter-associated bloodstream infection incidence and risk factors in adults with cancer: a prospective cohort study. J Hosp Infect. 2011 May;78(1):26-30. doi: 10.1016/j.jhin.2011.01.018. Epub 2011 Apr 2.
PubMed 21459476Chaukiyal P, Nautiyal A, Radhakrishnan S, Singh S, Navaneethan SD. Thromboprophylaxis in cancer patients with central venous catheters. A systematic review and meta-analysis. Thromb Haemost. 2008 Jan;99(1):38-43. doi: 10.1160/TH07-07-0446.
PubMed 18217132Khorana AA, Francis CW, Blumberg N, Culakova E, Refaai MA, Lyman GH. Blood transfusions, thrombosis, and mortality in hospitalized patients with cancer. Arch Intern Med. 2008 Nov 24;168(21):2377-81. doi: 10.1001/archinte.168.21.2377.
PubMed 19029504Schwarz RE, Groeger JS, Coit DG. Subcutaneously implanted central venous access devices in cancer patients: a prospective analysis. Cancer. 1997 Apr 15;79(8):1635-40.
PubMed 9118051Decousus H, Bourmaud A, Fournel P, Bertoletti L, Labruyere C, Presles E, Merah A, Laporte S, Stefani L, Piano FD, Jacquin JP, Meyer G, Chauvin F; ONCOCIP Investigators. Cancer-associated thrombosis in patients with implanted ports: a prospective multicenter French cohort study (ONCOCIP). Blood. 2018 Aug 16;132(7):707-716. doi: 10.1182/blood-2018-03-837153. Epub 2018 Jul 6.
PubMed 29980524
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Thromboembolic and Infectious Complications Related to Percutaneous Central Venous Catheters in Cancer - Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT02025894
- Acronym / sponsor ID
- ONCOCIP / 2010-01
- Conditions
- Cancer
- Keywords
- neoplastic solid tumour, PCVC, thromboembolic complications, infectious complications, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,032 participants (actual)
- Lead sponsor
- Institut de Cancérologie de la LoireUniversity, hospital or other
- Study start
- Jun 2010 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 1 Jan 2014 (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 risk factors for thromboembolic and /or infectious complications in 3,000 patients with solid tumor and receiving a Percutaneous Central Venous Catheter (PCVC). A better understanding of the risk factors for these complications in this population would then allow interventional studies to be proposed to assess the benefit of prophylactic procedures in a sub-group of patients at most risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCVCs | – | –Cohort of cancer patients with indication PCVC under the usual practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cohort of consecutive patients
Key inclusion criteria (1 listed)
- Patient with a neoplastic solid tumour with an indication for insertion of a PCVC.
Key exclusion criteria (3 listed)
- Haematological neoplasm pathology, PCVC removal scheduled within 2 weeks of insertion,
- Therapeutic doses of anticoagulants required at inclusion,
- PCVC inserted by the femoral vein
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
Thromboembolic complications:
Time frame: one year
Locoregional or disseminated infectious complications:
Time frame: one year
1 secondary outcome
Medical and economic consequences of these complications
Time frame: one year
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 7 Mar 2017.
- Background: PubMed 22335737Agnelli G, George DJ, Kakkar AK, Fisher W, Lassen MR, Mismetti P, Mouret P, Chaudhari U, Lawson F, Turpie AG; SAVE-ONCO Investigators. Semuloparin for thromboprophylaxis in patients receiving chemotherapy for cancer. N Engl J Med. 2012 Feb 16;366(7):601-9. doi: 10.1056/NEJMoa1108898.
- Background: PubMed 23217208Debourdeau P, Farge D, Beckers M, Baglin C, Bauersachs RM, Brenner B, Brilhante D, Falanga A, Gerotzafias GT, Haim N, Kakkar AK, Khorana AA, Lecumberri R, Mandala M, Marty M, Monreal M, Mousa SA, Noble S, Pabinger I, Prandoni P, Prins MH, Qari MH, Streiff MB, Syrigos K, Buller HR, Bounameaux H. International clinical practice guidelines for the treatment and prophylaxis of thrombosis associated with central venous catheters in patients with cancer. J Thromb Haemost. 2013 Jan;11(1):71-80. doi: 10.1111/jth.12071.
- Background: PubMed 21040443Saber W, Moua T, Williams EC, Verso M, Agnelli G, Couban S, Young A, De Cicco M, Biffi R, van Rooden CJ, Huisman MV, Fagnani D, Cimminiello C, Moia M, Magagnoli M, Povoski SP, Malak SF, Lee AY. Risk factors for catheter-related thrombosis (CRT) in cancer patients: a patient-level data (IPD) meta-analysis of clinical trials and prospective studies. J Thromb Haemost. 2011 Feb;9(2):312-9. doi: 10.1111/j.1538-7836.2010.04126.x.
- Background: PubMed 18404702Akl EA, Kamath G, Yosuico V, Kim SY, Barba M, Sperati F, Cook DJ, Schunemann HJ. Thromboprophylaxis for patients with cancer and central venous catheters: a systematic review and a meta-analysis. Cancer. 2008 Jun;112(11):2483-92. doi: 10.1002/cncr.23479.
- Background: PubMed 21459476Mollee P, Jones M, Stackelroth J, van Kuilenburg R, Joubert W, Faoagali J, Looke D, Harper J, Clements A. Catheter-associated bloodstream infection incidence and risk factors in adults with cancer: a prospective cohort study. J Hosp Infect. 2011 May;78(1):26-30. doi: 10.1016/j.jhin.2011.01.018. Epub 2011 Apr 2.
- Background: PubMed 18217132Chaukiyal P, Nautiyal A, Radhakrishnan S, Singh S, Navaneethan SD. Thromboprophylaxis in cancer patients with central venous catheters. A systematic review and meta-analysis. Thromb Haemost. 2008 Jan;99(1):38-43. doi: 10.1160/TH07-07-0446.
- Background: PubMed 19029504Khorana AA, Francis CW, Blumberg N, Culakova E, Refaai MA, Lyman GH. Blood transfusions, thrombosis, and mortality in hospitalized patients with cancer. Arch Intern Med. 2008 Nov 24;168(21):2377-81. doi: 10.1001/archinte.168.21.2377.
- Background: PubMed 9118051Schwarz RE, Groeger JS, Coit DG. Subcutaneously implanted central venous access devices in cancer patients: a prospective analysis. Cancer. 1997 Apr 15;79(8):1635-40.
- Derived from this study: PubMed 29980524Decousus H, Bourmaud A, Fournel P, Bertoletti L, Labruyere C, Presles E, Merah A, Laporte S, Stefani L, Piano FD, Jacquin JP, Meyer G, Chauvin F; ONCOCIP Investigators. Cancer-associated thrombosis in patients with implanted ports: a prospective multicenter French cohort study (ONCOCIP). Blood. 2018 Aug 16;132(7):707-716. doi: 10.1182/blood-2018-03-837153. Epub 2018 Jul 6.
- Related InfoLink provided by the sponsor.
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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.
Pierre Fournel, MD principal investigator
Institut Cancérologique Lucien Neuwirth
Hervé DECOUSUS, MDPhD study director
CIC - CHU DE SAINT-ETIENNE
Franck CHAUVIN, MDPhD study director
Institut cancérologique Lucien Neuwirth
27 sites 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 Institut de Cancérologie de la Loire at 27 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 1 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: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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 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?
Thromboembolic complications: (time frame: one year). The study lists 2 primary outcomes in all. 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 NCT02025894, which also lists 9 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 7 Mar 2017.