RECRUITING

Parathyroid Tumor Clonal Status

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Conditions

Parathyroid TumorPrimary Hyperparathyroidism

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To define the frequency of monoclonal-X and polyclonal-X tumors in PHPT participants having parathyroidectomy (PTX) and to define the relationship between parathyroid tumor clonal status and multiple gland neoplasia (MGN), we will compare surgical and pathologic outcomes to tumor clonal status in a multicenter cohort of patients having bilateral neck exploration (BNE) and PTX (primary objectives).

Official Title

A Phase 2 Biomarker Study of Parathyroid Tumor Clonal Status in Primary Hyperparathyroidism

Quick Facts

Study Start:2023-04-11
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05997810

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed with nonfamilial primary hyperparathyroidism biochemically confirmed by measurement of serum calcium and intact PTH within 60 days of enrollment.
  2. * Female.
  3. * Age ≥ 18 years
  4. * Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
  1. * Patients with a history of cervicofacial irradiation.
  2. * Patients with recurrent or persistent PHPT after prior PTX.
  3. * Patients with secondary hyperparathyroidism due to renal failure on renal replacement therapy (i.e. hemodialysis or peritoneal dialysis).
  4. * Patients with tertiary hyperparathyroidism due to renal failure with or without history of renal transplantation.
  5. * Patients receiving calcimimetic agents (e.g. cinacalcet / Sensipar) within 30 days of PTX.
  6. * Patients currently taking lithium or with a history of lithium use.
  7. * Pregnant patients

Contacts and Locations

Study Contact

John A Olson, MD
CONTACT
(314) 362-8020
jaolsol@wustl.edu
Kathleen Harris
CONTACT
(314) 273-1433
harrisk@wustl.edu

Study Locations (Sites)

University of Alabama-Birmingham
Birmingham, Alabama, 35233
United States
University of California-Department of Surgery
San Francisco, California, 94143
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-11
Study Completion Date2027-01

Study Record Updates

Study Start Date2023-04-11
Study Completion Date2027-01

Terms related to this study

Additional Relevant MeSH Terms

  • Parathyroid Tumor
  • Primary Hyperparathyroidism