Skin Reactions Related to Thoracic Implantable Chamber Dressings

NCT07158879 | Recruiting

• 1 other identifier: DATA240100 KPAREAC
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, multicenter cohort of 500 patients newly treated with systemic chemotherapy with CCI. The main objective of this study is to measure the incidence of skin reactions related to thoracic implantable chamber dressings.

Conditions

Skin Diseases

Keywords

cancers treated with chemotherapy; skin reaction; dressings

Outcome Measures

Primary Outcomes (1)

• Measuring the incidence of skin reactions associated with thoracic implantable chamber dressings

  Appearance of itching and/or erythema (defined as diffuse or localized congestive redness of the skin) at the dressing site

  through study completion, an average of 18 months

Secondary Outcomes (8)

• Identify risk factors for skin reactions to dressings

  through study completion, an average of 18 months

• Identify risk factors for skin reactions to dressings

  through study completion, an average of 18 months

• Identify risk factors for skin reactions to dressings

  through study completion, an average of 18 months

• Identify risk factors for skin reactions to dressings

  through study completion, an average of 18 months

• Estimate the consequences of these reactions in terms of therapeutic management (implementation of a specific skin treatment, postponement or cancellation of chemotherapy), complications (catheter infection), patient comfort and satisfaction.

  through study completion, an average of 18 months

Study Arms (1)

Thoracic catheter port / 1st line chemotherapy

patients treated with chemotherapy (first-line only) using a thoracic implantable catheter chamber

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with thoracic CCI treated with chemotherapy in a day hospital ward at the Institut Curie Paris or the Centre Hospitalier de Polynésie Française or the Uturoa Hospital (French Polynesia).

You may qualify if:

• Patients over 18 years of age
• New chemotherapy patients (1st line of treatment only)
• Thoracic PAC

You may not qualify if:

• PICC Line and femoral PAC;
• Patients undergoing treatment with bi-specific antibodies (e.g. tebentafusp);
• Disunion requiring treatment
• Patients treated for hematological cancer;
• Persons deprived of their liberty or under guardianship (including curatorship);
• Adults under court protection;
• Inability to participate in the study for geographical, social or psychological reasons.
• Opposition to data use

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (3)

Institut Curie

Paris, 75248, France

RECRUITING

Centre Hospitalier de Polynésie Française CHPF

Pirae, 98716, French Polynesia

NOT YET RECRUITING

Hôpital Uturoa

Uturoa, 98735, French Polynesia

NOT YET RECRUITING

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Betty LIMIER

  Institut Curie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Betty LIMIER

CONTACT

+33 1 44 32 43 65; betty.limier@curie.fr

Isabelle FROMANTIN, Ph.D

CONTACT

+33 1 44 32 44 28; isabelle.fromantin@curie.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: September 8, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-06

Locations

FR (1)