- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04294589
Evaluation of NETs in Patients With Solid Cancers Associated With a High Risk of Venous Thromboembolic Events (Flownet)
Evaluation of Neutrophil Extracellular Traps (NETs) by Flow Cytometry in Patients With Solid Cancers Associated With a High Risk of Venous Thromboembolic Events
Venous Thromboembolic Events (ETVs) are the second leading cause of death (9.2% of causes of death) in cancer patients after tumor progression (1). Indeed, cancer is associated with a 4 to 7-fold risk of ETV during chemotherapy (2). This complication is observed in 20% of cancer patients (3), and is sometimes an inaugural manifestation of cancer. This risk is particularly increased during the first 3 months after cancer diagnosis (4).
A biomarker correlated with the occurrence of ETVs would make it possible to target patients at high risk of thrombosis who could benefit from primary thromboprophylaxis, thus avoiding the complications, particularly haemorrhagic, and the additional costs associated with the long-term diagnostic and therapeutic management of ETVs. The investigator has implemented in the laboratory an innovative approach to the detection and quantification of circulating NETs by flow cytometry (FCM) allowing the routine determination of NETs. Therefore the investigator propose to assess NETs by CMF in a cohort of cancer patients with a very high risk of ETVs (pancreatic cancer, gastric cancer and colon cancer).
Studieoversikt
Status
Detaljert beskrivelse
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Haut De Seine
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Boulogne-Billancourt, Haut De Seine, Frankrike, 92100
- Rekruttering
- Ambroise Paré Hospital
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Ta kontakt med:
- Valerie Barder, PhD
- Telefonnummer: +33 149095413
- E-post: valerie.bardet@aphp.fr
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Male or Female over 18 years of age (≥18),
- Patient with pancreatic, gastric or colorectal cancer,
- Patient with a high risk of ETV,
- Patient on the first line of treatment or relapsing after a period of complete remission,
- Patient affiliated to a social security system or CMU.
Exclusion Criteria:
- Patient who has had an ETV in the 3 months prior to inclusion,
- Patient with a life expectancy of less than 3 months,
- Patient with an anticoagulation placement,
- Known pregnant or breastfeeding woman,
- Patient under guardianship or curatorship.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Show that the NETs rate is higher at diagnosis in solid cancer patients with ETV within 4 months of diagnosis compared to patients without ETV
Tidsramme: 16 months
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At the end of the study, after a minimum clinical follow-up of 4 months, the frequency of ETVs will be correlated to the NET rate measured in univariate and multivariate analysis (including also the following thrombotic risk factors: neutrophil levels, platelet levels, D-dimers, factor VIII, procoagulant activity of PM and body mass index).
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16 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Determine a threshold of NETs that optimizes management based on the consequences of classification errors through decision analysis
Tidsramme: 16 months
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The choice of an optimal threshold of NETs (sensitivity, specificity, likelihood ratio) will be determined by decision analysis using a decision tree combining probabilities of events and costs associated with fair (true positive, true negative) and erroneous (false positive, false negative) decisions.
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16 months
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Explore the possibility of a prognostic VTE score integrating the NET rate and other clinical and biological parameters measured at the time of cancer diagnosis
Tidsramme: 16 months
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The choice of an optimal threshold of NETs (sensitivity, specificity, likelihood ratio) will be determined by decision analysis using a decision tree combining probabilities of events and costs associated with fair (true positive, true negative) and erroneous (false positive, false negative) decisions.
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16 months
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Valérie BARDET, PhD, hematology immunology transfusion Service, Ambroise Pare hospital
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Khorana AA, Francis CW, Culakova E, Kuderer NM, Lyman GH. Thromboembolism is a leading cause of death in cancer patients receiving outpatient chemotherapy. J Thromb Haemost. 2007 Mar;5(3):632-4. doi: 10.1111/j.1538-7836.2007.02374.x. No abstract available.
- Chew HK, Wun T, Harvey D, Zhou H, White RH. Incidence of venous thromboembolism and its effect on survival among patients with common cancers. Arch Intern Med. 2006 Feb 27;166(4):458-64. doi: 10.1001/archinte.166.4.458.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- APHP190640
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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