Antiphospholipid SyndromeNOHA-KNCT03969498
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)
An observational study of Antiphospholipid Syndrome and Pregnancy Related, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Antiphospholipid Syndrome, Pregnancy Related, Cancer
- How many people
- 1,592 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2018to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- Women included into the NOH-APS cohort, lost to follow-up (N=37).
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Antiphospholipid Syndrome, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start2 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antiphospholipid SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,592 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969498
- Sponsor's protocol ID
- Local /2018/JCG-01
- Acronym
- NOHA-K
- Status last verified
- Jun 2023
- First submitted
- 28 May 2019
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31101755
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03969498
- Acronym / sponsor ID
- NOHA-K / Local /2018/JCG-01
- Conditions
- Antiphospholipid Syndrome, Pregnancy Related, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,592 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Women included into the NOH-APS cohort, lost to follow-up (N=37).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Results publication: PubMed 31101755Gris 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antiphospholipid Syndrome and Pregnancy Related, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the incidence of cancer diagnosis (time frame: 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03969498, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.