An Investigation of Pituitary Tumors and Related Hypothalmic Disorders

Launched by EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT (NICHD) · Nov 3, 1999

Keywords

ClinConnect Summary

This clinical trial is focused on studying tumors that affect the pituitary gland, which is an important part of the brain that controls various hormones in the body. The main goal is to understand the genetic factors that may lead to these tumors, especially in children and young adults. The researchers want to improve how these tumors are diagnosed and treated, and they will also train medical students and fellows on how to recognize and manage these conditions effectively.

To participate in this study, you or your child should be between the ages of 3 and 70 and have been diagnosed with a tumor in the hypothalamic-pituitary area, which can be confirmed through imaging tests or hormone level checks. Family members of patients with a history of these tumors can also join the study, particularly for genetic analysis. Participants can expect thorough evaluations and the opportunity to contribute to important research that could lead to better treatments in the future. Please note that pregnant individuals cannot participate in this trial.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• • 1. Stated willingness to comply with all study procedures and availability for the duration of the study.
• 2. Male or female with:
• • 1. Evidence for the existence of a tumor of the hypothalamic-pituitary unit or related disorder, as indicated by previously obtained imaging studies or biochemical investigation of the hypothalamo-hypophyseal function (aged 2 years to 70 years)
• • or
• • 2. Family members (any age) of patients with a family history of tumors of the hypothalamic-pituitary unit or related disorders as part of the linkage part of the study, or
• • 3. Members (any age) of a kindred suspected of having an inherited form of neoplasia of the hypothalamic-pituitary unit or related disorder, as evidenced by results of a patient enrolled in this protocol, as part of the linkage part of the study
• • 3. Ability of the subject or LAR to understand and the willingness to sign a written informed consent document.
• EXCLUSION CRITERIA:
• An individual who meets any of the following criteria will be excluded from participation in this study:
• • 1. Pregnancy: Pregnancy will be evaluated only in participants of reproductive age (from 10 years old until 60 years of age unless menopause has already occurred per clinical report of the participant).
• • For participants enrolled as external participants or under the Linkage study (where research activities include no more than blood draws), any female who could possibly become pregnant will be screened using clinical criteria (history, with pregnancy testing only if indicated) for exclusion and this information will be documented in the consent process note in EMR. If a participant has initially been registered as external location and then presents on-site, then pregnancy test will be performed if within the reproductive age group.
• • 2. Patients with any medical, physical, psychiatric, or social condition, which, in the opinion of the investigators, would make participation in this protocol not in their best interest, will be excluded from the study.
• • 3. Patients who are critically ill, unstable, or with severe organ failure that may affect/limit the endocrine evaluation and place unsustainable demands on CC or NICHD resources may be excluded.