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) (NOHA-K)

June 5, 2023 updated by: Centre Hospitalier Universitaire de Nīmes

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1592

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nîmes, France
        • CHUNimes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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)

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the incidence of cancer diagnosis
Time Frame: 2017
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

May 28, 2019

First Submitted That Met QC Criteria

May 28, 2019

First Posted (Actual)

May 31, 2019

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Local /2018/JCG-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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