Clinical trial NCT06444477: Molecular Analysis of Thrombocytopenia and Cancer (MATAC): Investigating Antigenic Mimicry Between Platelets and Tumor Cells in Patients With Immune Thrombocytopenia (ITP) Associated With Cancer
Official title: Molecular Analysis of Thrombocytopenia and Cancer (MATAC): Investigating Antigenic Mimicry Between Platelets and Tumor Cells in Patients With Immune Thrombocytopenia (ITP) Associated With Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Immune Thrombocytopenia
Immune Thrombocytopenic Purpura
Neoplasms
Cancer
Keywords: Proteomics
Mortality
Side Effects
Multicenter
Retrospective
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a definite diagnosis of both ITP and cancer

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Remission rate of ITP at 6 months after specific cancer treatment
timeFrame: At baseline (Day 0)
Secondary outcomes:
measure: All-cause mortality
timeFrame: At baseline (Day 0)
measure: Side effects related to ITP and its treatment
timeFrame: At baseline (Day 0)
measure: Side effects related to its treatment
timeFrame: At baseline (Day 0)
measure: Clinical description of the characteristics of ITP associated with a diagnosis of solid cancer
timeFrame: At baseline (Day 0)
measure: Biological description of the characteristics of ITP associated with a diagnosis of solid cancer
timeFrame: At baseline (Day 0)
measure: Demographic description of the characteristics of ITP associated with a diagnosis of solid cance
timeFrame: At baseline (Day 0)
measure: Therapeutic description of the characteristics of ITP associated with a diagnosis of solid cance
timeFrame: At baseline (Day 0)
Other outcomes:
Locations:
city: Bondy
country: France
facility: AP-HP Hôpital Jean Verdier service de médecine interne
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand - service de médecine interne
city: Créteil
country: France
facility: AP-HP Hôpital Mondor service de médecine interne
city: Le Kremlin-Bicêtre
country: France
facility: AP-HP Hôpital Bicêtre service de médecine interne
city: Lille
country: France
facility: CHU de Lille - service d'Hématologie
city: Lyon
country: France
facility: HCL - service d'Hématologie
city: Marseille
country: France
facility: AP-HM Hôpital la Timone - service de médecine interne
city: Montpellier
country: France
facility: CHU de Montpellier - service d'Hématologie
city: Nancy
country: France
facility: CHRU de Nancy - service de Médecine Interne et Immunologie Clinique
city: Nantes
country: France
facility: CHU de Nantes - service de médecine interne
city: Orléans
country: France
facility: CHRU d'Orléans - service de Médecine interne
city: Orléans
country: France
facility: CHRU d'Orléans - service de réanimation
city: Paris
country: France
facility: AP-HP Hôpital Bichat service de médecine interne
city: Paris
country: France
facility: AP-HP Hôpital Saint-Antoine service de médecine interne
city: Paris
country: France
facility: AP-HP Hôpital Saint-Louis service immuno-hématologie
city: Pessac
country: France
facility: CHU de Bordeaux Service de Médecine Interne et Maladies Infectieuses
city: Poitiers
country: France
facility: CHU de Poitiers - service de médecine interne
city: Strasbourg
country: France
facility: CHRU de Strasbourg - service de médecine interne
city: Toulouse
country: France
facility: CHU de Toulouse - service de médecine interne
city: Tours
country: France
facility: CHU de Tours - service de médecine interne
Study officials:
affiliation: University Hospital, Bordeaux
name: Etienne RIVIERE, MD
role: PRINCIPAL_INVESTIGATOR
References: