Symptoms and General Pathology

All Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Rare Diseases

Syndrome

Death

Antiphospholipid Syndrome

Fetal Death

Thrombophilia

Autoimmune Diseases

Hematologic Diseases

Pregnancy Complications

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

No intervention, pure observational 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).

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)

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.

Centre Hospitalier Universitaire de Nīmes

Skin and Connective Tissue Diseases

Musculoskeletal Diseases

Neoplasms

Infections

Mouth and Tooth Diseases

Eye Diseases

Nervous System Diseases

Heart and Blood Diseases

Scleroderma, Systemic

Scleroderma, Diffuse

Arthritis

Arthritis, Rheumatoid

Mastocytosis

Spondylitis

Sjogren's Syndrome

Arthritis, Psoriatic

Lupus Erythematosus, Systemic

Spondylarthritis

Myositis

Vasculitis

Joint Diseases

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Spondylarthropathies

Spinal Diseases

Bone Diseases

Psoriasis

Skin Diseases

Skin Diseases, Papulosquamous

Xerostomia

Salivary Gland Diseases

Mouth Diseases

Stomatognathic Diseases

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Lacrimal Apparatus Diseases

Vascular Diseases

Disease Attributes

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Mast Cell Activation Disorders

Muscular Diseases

Neuromuscular Diseases

Systemic Scleroderma

Idiopathic Inflammatory Myopathy

Spondylarthropathy

Nathalie Costedoat-Chalumeau, PhD

Adèle Bellino

nathalie Costedoat-Chalumeau, PhD

Rare diseases frequently affect women of childbearing age. Pregnancy in these women has become less rare, but remains associated with high levels of complications. One obstacle to their optimal management during pregnancy is that there are no prospective studies of pregnancy during rare diseases and several connective tissue diseases. As a consequence, the management of these pregnancies is non-standardised in terms of treatment, monitoring (frequency of consultations, laboratory tests and ultrasound), and organisation of care.

Moreover, although these women (all diseases combined) are frequently exposed to medications potentially incompatible with pregnancy, little is known about the frequency of these exposures and especially their consequences to mother and child.

For these reasons, researchers and clinicians from different specialties created an interdisciplinary research group on pregnancy and rare diseases (GR2), intended to improve the management of these patients' pregnancies. Using a single computer server, the investigators plan to set up a large prospective study of pregnancies in patients with rare diseases: various forms of myositis, lupus, antiphospholipid syndrome, Sjogren syndrome, scleroderma, and inflammatory rheumatic diseases. The investigators objective is to analyse the complications of pregnancies in women with rare diseases and then to improve their management and their quality of life.

Pregnancy and Medically Assisted Conception in Rare Diseases

Prospective Observational Study About Pregnancy and Medically Assisted Conception in Rare Diseases

It's a composite outcome . A pregnancy with no severe maternal complication (by the Epimoms\* definition), live birth after 35 weeks' gestation, a birth weight \>10th percentile of the general population and no infections (maternal and infant) during pregnancy and first year of follow up, respectively

About the organisation of care (analysis of the effect on outcome of the number of ultrasound examinations and clinician visits, and the systematic planning of delivery)

Analyse the frequency of exposure to various medications (immunosuppressors, biological therapy, corticosteroids) and their maternal and fetal consequences (e.g., infectious complications).

Within an existing collection with (1) samples taken during the first trimester of pregnancy to analyse markers that might predict subsequent obstetric complications (cytokines, growth factors, enzymes) (2) with cord blood samples (which will, in particular, enable immunological and pharmacological analyses).

SNFMI

CRAT

Assistance Publique - Hôpitaux de Paris

Study title	NCT ID	Conditions	Eligibility	Organization
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	Antiphospholipi... Pregnancy Relat... Cancer	18 Years -	Centre Hospitalier Universitaire de Nīmes
Pregnancy and Medically Assisted Conception in Rare Diseases	NCT02450396	Rheumatoid Arth... Spondyloarthrit... Psoriatic Arthr... Systemic Lupus ... Antiphospholipi... Sjogren Syndrom... Scleroderma Myositis Vasculitis Mastocytosis Various Autoimm...	-	Assistance Publique - Hôpitaux de Paris
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	Antiphospholipi... Pregnancy Relat... Cancer	18 Years -	Centre Hospitalier Universitaire de Nīmes
Pregnancy and Medically Assisted Conception in Rare Diseases	NCT02450396	Rheumatoid Arth... Spondyloarthrit... Psoriatic Arthr... Systemic Lupus ... Antiphospholipi... Sjogren Syndrom... Scleroderma Myositis Vasculitis Mastocytosis Various Autoimm...	-	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for antiphospholipid syndrome