Evaluation of NETs in Patients With Solid Cancers Associated With a High Risk of Venous Thromboembolic Events

NCT04294589 | Unknown DMC

• 1 other identifier: APHP190640
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pancreatic Cancer; Gastric Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  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).

  16 months

Secondary Outcomes (2)

• Determine a threshold of NETs that optimizes management based on the consequences of classification errors through decision analysis

  16 months

• 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

  16 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People with pancreatic, gastric or colorectal cancer at high risk of ETV, on the first line of treatment or relapsing after a period of complete remission.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Ambroise Pare Hospital

Boulogne-Billancourt, Haut de Seine, 92100, France

RECRUITING

Related Publications (2)

• 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.

  PMID: 17319909 BACKGROUND

• 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.

  PMID: 16505267 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Stomach Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Valérie BARDET, PhD

  hematology immunology transfusion Service, Ambroise Pare hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie BARDET, PhD

CONTACT

(+33) 1.49.09.54.13; valerie.bardet@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 4, 2020
• Study Start: July 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)