Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06444477
Other study ID # CHUBX 2024/16
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2024
Est. completion date December 2024

Study information

Verified date May 2024
Source University Hospital, Bordeaux
Contact Etienne RIVIERE, MD
Phone (0)557656483
Email etienne.riviere@chu-bordeaux.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The association between hematologic malignancies and ITP is well described, but this link is much less clear with solid cancers. In cases of ITP associated with cancers, specific cancer treatment can lead to remission or even cure of ITP. Thus, our hypothesis was that chronic expression of GPIIB by tumor cells could have initiated an autoimmune loop against GPIIB, leading to the onset and perpetuation of ITP.


Description:

Autoimmune thrombocytopenia, also known as immune thrombocytopenic purpura (ITP), is a rare autoimmune disease characterized by platelet destruction and impaired production, posing a life-threatening risk due to bleeding complications. The pathophysiology of ITP involves complex mechanisms, including both defective platelet production and auto-reactivity of B and T lymphocytes leading to the production of autoantibodies against platelets, found in 35 to 55% of cases. Additionally, in the context of neoplasia, some patients may develop varying degrees of thrombocytopenia, exacerbating morbidity and mortality. A multicenter, retrospective study will collect data from routine care, including birth date, gender, biological parameters related to ITP, dates of treatment initiation and diagnosis of ITP and cancer, types of treatments, and outcomes such as survival or death, without additional medical interventions or appointments.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients with a definite diagnosis of both ITP and cancer; - Synchronous diagnosis of ITP and cancer; - Onset of ITP occurring 6 months before or after the diagnosis of cancer. Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ITP and cancer
ITP and cancer

Locations

Country Name City State
France AP-HP Hôpital Jean Verdier service de médecine interne Bondy
France CHU de Clermont-Ferrand - service de médecine interne Clermont-Ferrand
France AP-HP Hôpital Mondor service de médecine interne Créteil
France AP-HP Hôpital Bicêtre service de médecine interne Le Kremlin-Bicêtre
France CHU de Lille - service d'Hématologie Lille
France HCL - service d'Hématologie Lyon
France AP-HM Hôpital la Timone - service de médecine interne Marseille
France CHU de Montpellier - service d'Hématologie Montpellier
France CHRU de Nancy - service de Médecine Interne et Immunologie Clinique Nancy
France CHU de Nantes - service de médecine interne Nantes
France CHRU d'Orléans - service de Médecine interne Orléans
France CHRU d'Orléans - service de réanimation Orléans
France AP-HP Hôpital Bichat service de médecine interne Paris
France AP-HP Hôpital Saint-Antoine service de médecine interne Paris
France AP-HP Hôpital Saint-Louis service immuno-hématologie Paris
France CHU de Bordeaux Service de Médecine Interne et Maladies Infectieuses Pessac
France CHU de Poitiers - service de médecine interne Poitiers
France CHRU de Strasbourg - service de médecine interne Strasbourg
France CHU de Toulouse - service de médecine interne Toulouse
France CHU de Tours - service de médecine interne Tours

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Remission rate of ITP at 6 months after specific cancer treatment At baseline (Day 0)
Secondary All-cause mortality At baseline (Day 0)
Secondary Side effects related to ITP and its treatment At baseline (Day 0)
Secondary Side effects related to its treatment At baseline (Day 0)
Secondary Clinical description of the characteristics of ITP associated with a diagnosis of solid cancer At baseline (Day 0)
Secondary Biological description of the characteristics of ITP associated with a diagnosis of solid cancer At baseline (Day 0)
Secondary Demographic description of the characteristics of ITP associated with a diagnosis of solid cance At baseline (Day 0)
Secondary Therapeutic description of the characteristics of ITP associated with a diagnosis of solid cance At baseline (Day 0)
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients