Evaluation of the Incidence of Cancer in the Follow-up of Women With 3 Consecutive Embryonic Demises Before 10 Weeks or 1 Fetal Death, According to Their Thrombophilia Status, With a Special Focus on Women With an Obstetric Antiphospholipid Symdrome (oAPS)

NCT03969498 | Completed

• 1 other identifier: Local /2018/JCG-01
• Study Type: observational
• Target: 1,592
• Locations: 1 country
• Sites: 1

Brief Summary

A number of case reports describe the association of antiphospholipid antibodies (aPL Abs) with hematological and solid organ malignancies. Especially in elderly patients, thrombotic events associated with aPL Abs can be the first manifestation of malignancy. Cancer-associated monoclonal gammopathy of the IgM type can be accompanied by positive lupus anticoagulant (LA) or an anticardiolipin (aCL) IgM. Cancer and antiphospholipid antibody syndrome (APS) can coexist in sporadic cases, while some cancer patients with or without thrombosis may show some transitory aPL Ab positivity, the most striking symptomatic clinical feature, catastrophic APS, being even described in cancer patients. Some reports suggest a significant incidence of malignancies in APS patients. Cancer was the 2nd cause of death (13.9%), after bacterial infection, during the 10-year follow-up of the 1,000 APS patients studied by the Euro-Phospholipid Project Group, but no control group was simultaneously evaluated. The risk of cancer in patients with APS is thus still uncertain. The Nîmes Obstetricians and Haematologists APS (NOH-APS) study was based on the recruitment of a cohort of women with no history of thrombosis, who had experienced pregnancy loss fulfilling the clinical criteria of obstetrical APS (oAPS), who were either positive for aPL Abs (APS group), or positive for the F5 rs6025 or F2 rs1799963 polymorphism (Thrombophilia group), or negative for thrombophilia screening (Control group). We now want to assess the comparative incidence of cancer in women for whom an oAPS diagnosis had been made. This evaluation will be carried out during the 2017 medical follow-up step, corresponding to a median follow-up of 17 years. An external, local population-derived control group, the registry of tumors in Montpellier area (Registre des Tumeurs de l'Hérault) will be used to compute standardized incidence ratios (SIRs).

Conditions

Antiphospholipid Syndrome; Pregnancy Related; Cancer

Outcome Measures

Primary Outcomes (1)

• Comparison of the incidence of cancer diagnosis

  Comparison of the incidence of cancer diagnosis during the follow-up of patients included between January 1, 1995 and January 1, 2005, evaluated at the date of the annual consultation of 2017, in 3 groups of women sharing the same initial clinical symptoms (NOH-APS cohort), categorized according to the results of thrombophilia screening.

  2017

Study Arms (3)

1- Obstetric APS women (oAPS)

No intervention, pure observational study.

2-Women positive for F5rs6025 or F2rs1799963 polymorphis

No intervention, pure observational study.

3-Women with negative thrombophilia screening (Control group

No intervention, pure observational study.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

3 groups of women : 1. Obstetric APS women (oAPS) 2. Women positive for the F5 rs6025 or F2 rs1799963 polymorphism (Thrombophilia group) 3. Women with a negative thrombophilia screening (Control group)

You may qualify if:

• Women initially included into the NOH-APS cohort (N=1,592): no history of thrombosis, pregnancy loss fulfilling the clinical criteria of obstetrical APS, i.e. 3 unexplained consecutive embryonic demises before 10 weeks or 1 unexplained fetal death

You may not qualify if:

• Women included into the NOH-APS cohort, lost to follow-up (N=37).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHUNimes

Nîmes, France

Location

Related Publications (1)

• Gris JC, Mousty E, Bouvier S, Ripart S, Cochery-Nouvellon E, Fabbro-Peray P, Broner J, Letouzey V, Perez-Martin A. Increased incidence of cancer in the follow-up of obstetric antiphospholipid syndrome within the NOH-APS cohort. Haematologica. 2020 Jan 31;105(2):490-497. doi: 10.3324/haematol.2018.213991. Print 2020.

  PMID: 31101755 RESULT

MeSH Terms

Conditions

Antiphospholipid Syndrome; Neoplasms

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: May 31, 2019
• Study Start: January 2, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: December 1, 2025

Record last verified: 2023-06

Locations

FR (1)