Breast CancerCAVECCASNCT00714909
Determination of Predictive Value of Echography Doppler Abnormalities
An observational study of Breast Cancer and Upper Extremity Deep Vein Thrombosis, Secondary, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In order to avoid to use a traumatic and iatrogenic examen (phlebography), the purpose of the study is to validate echography doppler in the diagnosis of asymptomatic related catheter related thrombosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Upper Extremity Deep Vein Thrombosis, Secondary
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to May 2012
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients treated receiving adjuvant chemotherapy for localized breast cancer in the participating centers
Who may be able to join
- women over 18
- histologically proven breast cancer
- localized breast cancer without metastasis
- adjuvant or neo adjuvant chemotherapy
- insertion of central catheter with port for chemotherapy
- central catheter for more than three months
- inform consent
- follow up for three months
Who cannot join
- ongoing anticoagulant therapy
- previous central catheter
- femoral catheter
- double lumen catheter
- central catheter without port
- platelets < 80G/L, TQ < 50%, fibrinogen < 1 g/L
- creatinin > 175mole/L
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Saint-Louis Hospital
Paris, 75010
Philippe M Debourdeau, MD, +33 1 4249 9768, onco.debourdeau@yahoo.fr
Philippe M Debourdeau, MD
About this study
Official title: CAVECCAS Value of Risk Factors for Symptomatic Catheter Related Thrombosis in Patients With Breast Cancer Treated With Adjuvant Chemotherapy
In order to avoid to use a traumatic and iatrogenic examen (phlebography), the purpose of the study is to validate echography doppler in the diagnosis of asymptomatic related catheter related thrombosis.
Read the detailed description
Phlebography is the gold standard for the diagnosis of asymptomatic catheter related thrombosis but can not be performed in about 15% of patients because of arm swelling and lack of superficial veins.
Echography doppler is an easy, cheap and atraumatic way to make the diagnosis of deep vein thrombosis. The value of echography doppler has been proven for the diagnosis of symptomatic deep venous thrombosis of lower and upper limbs and for the diagnosis of proximal asymptomatic lower limbs.
To validate the echography doppler we intend to correlate asymptomatic findings to the occurrence symptomatic related catheter related thrombosis.
Patients with localized breast cancer treated with chemotherapy will be enrolled in the study. An echography doppler will be performed on day 8, 30 and 90 after catheter insertion. Findings in asymptomatic patients (thrombus visualisation, lack of vein compressibility, variation of physiologic vein blood flow) will thereafter be correlated with the presence or absence of clinical signs of catheter related thrombosis.
In order to assess if they are risk factors for catheter related thrombosis, we will determine the level D-Dimer, microparticles and the results of generation thrombin tests before and 2 days after catheter insertion.
- Keywords
- Breast cancer, Catheter related thrombosis, Diagnosis, Echography doppler, Risk factors
- Medical subject headings
- Breast Neoplasms, Upper Extremity Deep Vein Thrombosis, Disease
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 |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic catheter related thrombosis, as confirmed by echography doppler, phlebography or angiography scan
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2011 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Philippe M Debourdeau, MD, Principal investigator, Saint-Louis Hospital, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714909
- Sponsor's protocol ID
- K070104
- Acronym
- CAVECCAS
- Status last verified
- Feb 2011
- First submitted
- 11 Jul 2008
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAVECCAS Value of Risk Factors for Symptomatic Catheter Related Thrombosis in Patients With Breast Cancer Treated With Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT00714909
- Acronym / sponsor ID
- CAVECCAS / K070104
- Keywords
- Breast cancer, Catheter related thrombosis, Diagnosis, Echography doppler, Risk factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2011 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 14 Jul 2008 (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.
In order to avoid to use a traumatic and iatrogenic examen (phlebography), the purpose of the study is to validate echography doppler in the diagnosis of asymptomatic related catheter related thrombosis.
Detailed description
Phlebography is the gold standard for the diagnosis of asymptomatic catheter related thrombosis but can not be performed in about 15% of patients because of arm swelling and lack of superficial veins.
Echography doppler is an easy, cheap and atraumatic way to make the diagnosis of deep vein thrombosis. The value of echography doppler has been proven for the diagnosis of symptomatic deep venous thrombosis of lower and upper limbs and for the diagnosis of proximal asymptomatic lower limbs.
To validate the echography doppler we intend to correlate asymptomatic findings to the occurrence symptomatic related catheter related thrombosis.
Patients with localized breast cancer treated with chemotherapy will be enrolled in the study. An echography doppler will be performed on day 8, 30 and 90 after catheter insertion. Findings in asymptomatic patients (thrombus visualisation, lack of vein compressibility, variation of physiologic vein blood flow) will thereafter be correlated with the presence or absence of clinical signs of catheter related thrombosis.
In order to assess if they are risk factors for catheter related thrombosis, we will determine the level D-Dimer, microparticles and the results of generation thrombin tests before and 2 days after catheter insertion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients treated receiving adjuvant chemotherapy for localized breast cancer in the participating centers
Key inclusion criteria (8 listed)
- women over 18
- histologically proven breast cancer
- localized breast cancer without metastasis
- adjuvant or neo adjuvant chemotherapy
- insertion of central catheter with port for chemotherapy
Key exclusion criteria (7 listed)
- ongoing anticoagulant therapy
- previous central catheter
- femoral catheter
- double lumen catheter
- central catheter without port
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
Symptomatic catheter related thrombosis, as confirmed by echography doppler, phlebography or angiography scan
Time frame: within 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2011.
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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.
Philippe M Debourdeau, MD principal investigator
Saint-Louis Hospital, Paris, 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 Breast Cancer and Upper Extremity Deep Vein Thrombosis, Secondary, run by Assistance Publique - Hôpitaux de Paris 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 8 inclusion and 7 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 Feb 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe M Debourdeau, MD (+33 1 4249 9768, onco.debourdeau@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic catheter related thrombosis, as confirmed by echography doppler, phlebography or angiography scan (time frame: within 6 months). 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 23 Feb 2011.