Craniopharyngioma and Pregnancies

NCT06801756 | Recruiting

• 1 other identifier: APHP241441
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Craniopharyngioma

Keywords

pregnancy

Outcome Measures

Primary Outcomes (1)

• Describe how pregnancies are obtained: spontaneous or induced (and by which assisted reproduction technique).

  Information on how the pregnancy was obtained will be collected from the medical record and will be completed on the day of inclusion by a telephone questionnaire with the patient.

  12 months

Secondary Outcomes (7)

• Describe the existence of a parental project among the women in the cohort

  12 months

• Describe obstetric outcomes

  12 months

• Describe hormonal replacement adaptations.

  12 months

• Describe the evolution of tumor volume during pregnancy or postpartum

  12 months

• Describe the visual impact if any

  12 months

Interventions

Questionnaire OTHER

The patients will respond to a questionnaire about their parental project, the occurence or not of complications during the pregnancy, and the impact of pregnancy on craniopharyngioma.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only female will be included
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with or having had a craniopharyngioma followed in the Endocrinology and Reproductive Medicine department at Pitié Salpêtrière, Paris, France

You may qualify if:

• Patients aged at least 18 years old
• Patients with or having had a craniopharyngioma
• Patients informed and not opposed to participation in research

You may not qualify if:

• Patients who don't speak french
• Patients without medical care insurance
• Patients under legal protection

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pitié-Salpêtrière hospital

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Craniopharyngioma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Anne BACHELOT, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Central Study Contacts

Anne BACHELOT, MD, PhD

CONTACT

01 42 16 02 46; anne.bachelot@aphp.fr

Zeina Chakhtoura, MD

CONTACT

01 42 16 02 20; zeina.chakhtoura@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 30, 2025
• Study Start: March 24, 2025
• Primary Completion: March 24, 2026
• Study Completion: March 24, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

FR (1)