Last updated: September 1, 2023
Sponsor: Institut Cancerologie de l'Ouest
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
Physiological serum injection
Contrast agent injection
Clinical Study ID
NCT05100355
ICO-2021-07
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Female or male, Age ≥ 18 years at time of study entry.
- Undergoing systemic chemotherapy on a CVC. Immunotherapy and targeted therapies areamong the systemic therapies that are authorised
- Having already received at least one administration of treatment without difficulty.
- Coming for a new administration of treatment authorised by the usual biologicalassessment.
- First episode of lack of CVC blood return despite the usual positioning and injection-aspiration manoeuvres
- No abnormality on inspection or palpation (turning) of the CVC.
- Patient has valid health insurance.
- Patient information and signature of informed consent.
Exclusion
Exclusion Criteria:
- Previous episode of lack of CVC blood return whether explored or not.
- Patient currently treated in an interventional therapeutic trial.
- Patient with a Picc-line implantable device.
- Suspected CVC infection or thrombosis.
- Planned chemotherapy with vesicant agent (anthracyclines).
- Possible CVC disjunction.
- Allergy to X-ray contrast agent or creatinine clearance below 30ml/min prohibiting aniodine injection.
- Pregnant, likely to be pregnant or breastfeeding woman.
- Persons deprived of their liberty, under a measure of safeguard of justice, underguardianship or placed under the authority of a guardian.
- Impossibility of undergoing medical monitoring of the trial for geographical, socialor psychological reasons, social or psychological reasons.
Study Design
Total Participants: 108
Treatment Group(s): 2
Primary Treatment: Physiological serum injection
Phase:
Study Start date:
March 09, 2022
Estimated Completion Date:
June 30, 2025
Study Description
Connect with a study center
Institut de Cancérologie de l'Ouest
Angers, 49055
FranceActive - Recruiting
Institut du Cancer Sainte Catherine Avignon Provence
Avignon, 80005
FranceTerminated
Ch Cholet
Cholet, 49300
FranceActive - Recruiting
CHD La Roche Sur yon
La Roche-sur-Yon, 85925
FranceActive - Recruiting
Centre Eugène Marquis
Rennes, 35042
FranceSite Not Available
CH Yves Le Foll
Saint-Brieuc, 22023
FranceSite Not Available
Audrey ROLLOT
Saint-Herblain, 44805
FranceActive - Recruiting
Centre Hospitalier de St Malo
Saint-Malo, 35400
FranceActive - Recruiting
CHBA Vannes
Vannes, 56017
FranceActive - Recruiting
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