Craniopharyngioma and Pregnancies

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Study Purpose

Craniopharyngiomas (CP) are rare hypothalamic-pituitary tumors found in young children, adolescents and adults. The management of PC remains complex, as their aggressive nature, invasive behavior and propensity to recur require sequential and balanced therapeutic attitudes, as well as follow-up in an expert center. Although patient survival rates are high, the consequences of the tumor and its treatment can lead to serious comorbidities and impaired quality of life, particularly in patients whose tumors extend to the hypothalamus. There is very little literature describing the outcome of pregnancy in craniopharyngioma patients and its impact on the craniopharyngioma. The largest study describes 6 women, mean age 24, who had a craniopharyngioma in childhood. Half of them had induced pregnancies; there is a succinct description of pregnancy complications and outcomes, as well as tumor progression. In the endocrinology department of Pitié Salpêtrière hospital, the investigators regularly follow over a hundred patients of all ages who have presented with a craniopharyngioma in childhood or adulthood. They are also unique in having a medically assisted reproduction unit, which helps couples to realize their parental project. This dual specialization will enable to describe pregnancies and their impact on the behavior of craniopharyngiomas.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	Female

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients aged at least 18 years old.

- Patients with or having had a craniopharyngioma.

- Patients informed and not opposed to participation in research.

Exclusion Criteria:

- Patients who don't speak french.

- Patients without medical care insurance.

- Patients under legal protection

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06801756
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Assistance Publique - Hôpitaux de Paris
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Anne BACHELOT, MD, PhD
Principal Investigator Affiliation	Assistance Publique - Hôpitaux de Paris
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Craniopharyngioma

Additional Details

Craniopharyngiomas are benign, slow-growing epithelial tumors that develop from the pituitary stem or pituitary gland in the sellar and/or parasellar region. They account for 2-4% of intracranial tumours and 5.6-15% of childhood tumours. The age distribution at diagnosis of these tumors is bimodal, with a first peak of incidence in children aged 5 to 14, and a second peak in adults aged 50 to 74. Despite the benign nature of these lesions, the quality of life of affected patients is most often impaired, due to endocrine (panhypopituitarism, hypothalamic obesity), visual and neuro-intellectual sequelae associated with the tumor itself and/or its treatment, as well as a high rate of local recurrence. Treatment is mainly surgical, with the aim of removing as much of the tumour as possible and reducing the rate of local recurrence. However, this procedure has a high morbidity and mortality rate, without preventing a significant risk of recurrence (up to 62% at 10 years). Treatment is often complemented by radiotherapy or proton therapy to improve tumor control. Craniopharyngioma patients have an overall mortality rate 3 to 5 times higher than that observed in the general population. Increased morbidity is also observed in relation to hypopituitarism, hypothalamic lesions, visual and neurocognitive deficits, reduced quality of life and the development of cardiovascular risk factors. The literature describing pregnancy in women with craniopharyngioma and the impact on the tumor is almost non-existent. A case report published in 2002 relates the story of a patient whose craniopharyngioma was discovered following visual disturbances and operated on at the age of 8; she presented with secondary panhypopituitarism, other complications are not mentioned. She became pregnant at the age of 34 after 8 cycles of gonadotropin stimulation. The pregnancy was uneventful and she delivered at term after spontaneous labor a eutrophic daughter weighing 3,450 g. She did not lactate. During pregnancy, it was necessary to increase the doses of L-thyroxine, hydrocortisone and desmopressin, which were resumed at the usual doses 3 weeks after delivery. No mention was made of changes in tumour volume, visual disturbances, neurocognitive disorders or weight gain during pregnancy. The largest study described 6 women, mean age 24, who had had a craniopharyngioma in childhood. Four of them had at least one pituitary deficiency, half of them had had induced pregnancies; there appeared to be no obstetric complications, no description was made of tumor evolution, hormone substitutions, weight. The aim of this study is to carry out a monocentric study on patients followed in the endocrinology and reproductive medicine department of the Pitié-Salpêtrière hospital. This department is the constituent center of the CRESCENDO CRMR, which includes craniopharyngiomas, and one of the reference endocrinology departments for craniopharyngiomas in Ile-de-France, so it has the expertise and one of the largest populations of patients with this rare pathology in the region. The cohort is the result of two main recruitments:

- Craniopharyngiomas revealed in childhood: by pediatric endocrinology departments as part of the child-adult transition.

- Craniopharyngiomas diagnosed in adulthood: by the neurosurgery department of the Pitié-Salpêtrière hospital and by our private correspondents.

The literature on pregnancy in women with craniopharyngiomas is almost non-existent. The investigators would first like to know the proportion of women followed in the department who had a parental project, and whether the pregnancies were obtained naturally or through the use of antiretroviral treatment. They will describe the occurrence or non-occurrence of complications during pregnancy, the outcome of pregnancies and the impact of pregnancy on craniopharyngioma. To do this, the patients will be asked to fill in questionnaires relating mainly to their pregnancy, and the informations will be supplemented from medical records. The investigators plan to carry out this work over a period of one year. They consider this period sufficient to mail the letter of information and non-opposition to the 100 patients eligible for this work. Patients who do not object to their participation will then be contacted by telephone to complete a questionnaire. Each patient's participation will therefore last around thirty minutes.

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