How estrogen changes before diagnosis affect prolactinoma size
Influence of Pre-diagnostic Estrogen Fluctuations on the Development of Prolactin-Secreting Macroadenomas or Microadenomas: A Comparative Study Conducted at Hôpital Louis Pradel
This research will test whether changes in estrogen levels before diagnosis are linked to tumor size in adult women with prolactin-secreting macroadenomas.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Bron, Rhone) |
| Trial ID | NCT07268183 on ClinicalTrials.gov |
What this trial studies
This is an observational study using a standardized questionnaire and review of clinical records to relate hormone history to tumor size at diagnosis. Researchers will include adult women diagnosed with prolactin-secreting macroadenomas between 2013 and 2023 who had at least part of their follow-up at Hôpital Louis Pradel. Diagnosis requires pituitary MRI showing an adenoma ≥10 mm plus elevated prolactin or confirmatory response to therapy or pathology, and available clinical data will be analyzed for estrogen exposure or fluctuation patterns before diagnosis. The team will compare hormonal histories with imaging and prolactin levels to look for associations that might explain sex- and age-related differences in tumor presentation.
Who should consider this trial
Good fit: Adult women (aged 18 or older) with a prolactin-secreting macroadenoma diagnosed from January 2013 to December 2023 who had at least some follow-up at Hospices Civils de Lyon and have the required MRI and prolactin data are eligible.
Not a fit: Men, people with microprolactinomas, those diagnosed outside the 2013–2023 window, or patients without HCL follow-up or the required MRI/prolactin records are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, this could help identify hormonal patterns that predict larger tumors and support earlier monitoring or more personalized management for women at risk.
How similar studies have performed: Previous basic and clinical research supports estrogen’s role in prolactinoma biology, but few observational studies have directly linked pre-diagnostic estrogen fluctuations to tumor size, so this approach is partly novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria of cases : * Female patients aged ≥ 18 years at recruitment (diagnosis may have occurred before age 18). * Diagnosis of a prolactin-secreting macroadenoma established between January 2013 and December 2023. The diagnosis may have been made either in the Endocrinology Department of Hôpital Louis Pradel or by another medical team, whether within or outside the hospital setting. However, follow-up or part of the follow-up must have been performed in the Endocrinology Department of Hospices Civils de Lyon (HCL) * Diagnosis established by : A hypothalamic-pituitary MRI centered on the sella turcica, performed with gadolinium injection, including fine T1-weighted coronal and sagittal slices (1.5-3 mm), showing an adenoma with at least one axis measuring \> 10 mm, AND Serum prolactin \> 100 µg/L, or 24-100 µg/L with either a favorable response to medical therapy or histopathological confirmation after surgery. * Ability to understand the study and provide informed non-opposition. Inclusion Criteria of controls : * Female patients aged ≥ 18 years at the time of recruitment (diagnosis may have occurred before age 18). * Diagnosis of a prolactin-secreting microadenoma established between January 2013 and December 2023. The diagnosis may have been made in any medical center, but follow-up or part of the follow-up must have been carried out in the Endocrinology Department of Hôpital Louis Pradel. * Diagnosis must be based on: A hypothalamic-pituitary MRI centered on the sella turcica, performed with gadolinium injection, including fine T1-weighted coronal and sagittal slices (1.5-3 mm), showing a prolactin-secreting adenoma with all axes measuring \< 10 mm, AND A biological assessment performed outside any condition likely to bias results (significant stress, physical exertion, pregnancy, or intake of hyperprolactinemia-inducing drugs unrelated to prolactinoma treatment), showing serum prolactin \> 24 µg/L. * Ability to understand the nature and implications of the study and to provide informed non-opposition to participation. Exclusion Criteria of cases : * Presence of a non-secreting macroadenoma. * History of isolated hyperprolactinemia or an isolated pituitary lesion documented prior to 2013, without subsequent direct diagnosis of prolactinoma. * Presence of a known genetic abnormality or a genetic syndrome predisposing to the development of a prolactin-secreting adenoma. Exclusion Criteria of controls : * Presence of a non-secreting microadenoma. * Uncertain diagnosis of adenoma with an ongoing therapeutic trial. * Isolated hyperprolactinemia without evidence of adenoma. * Hyperprolactinemia or pituitary lesion without hyperprolactinemia documented prior to 2013, without subsequent direct diagnosis of prolactinoma. * Presence of a known genetic abnormality or a genetic syndrome predisposing to the development of a prolactin-secreting adenoma
Where this trial is running
Bron, Rhone
- Hopital Louis Pradel — Bron, Rhone, France (Recruiting)
Study contacts
- Study coordinator: Gerald RAVEROT, Pr
- Email: gerald.raverot@chu-lyon.fr
- Phone: 04 27 85 66 66
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.