Parathyroid Tumor Clonal Status

NCT05997810 | Recruiting

• 1 other identifier: 202212100
• Study Type: observational
• Target: 839
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Parathyroid Tumor; Primary Hyperparathyroidism

Outcome Measures

Primary Outcomes (3)

• Primary Endpoint 1

  Frequency of occurrence of monoclonal-X versus polyclonal-X parathyroid tumors in a prospective multi-center cohort of patients having parathyroidectomy for primary hyperparathyroidism.

  24 months

• Primary Endpoint 2

  Determine clinicopathologic features of monoclonal-X versus polyclonal-X parathyroid tumors in a prospective multi-center cohort of patients with PHPT referred for PTX.

  24 months

• Primary Endpoint 3

  Perform a prospective study of biochemical outcomes of PTX in PHPT patients with monoclonal-X and polyclonal-X tumors.

  24 months

Secondary Outcomes (1)

• Secondary Endpoint

  24 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Females scheduled to have surgery for primary hyperparathyroidism.

You may qualify if:

• Diagnosed with nonfamilial primary hyperparathyroidism biochemically confirmed by measurement of serum calcium and intact PTH within 60 days of enrollment.
• Female.
• Age ≥ 18 years
• Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

You may not qualify if:

• Patients with a history of cervicofacial irradiation.
• Patients with recurrent or persistent PHPT after prior PTX.
• Patients with secondary hyperparathyroidism due to renal failure on renal replacement therapy (i.e. hemodialysis or peritoneal dialysis).
• Patients with tertiary hyperparathyroidism due to renal failure with or without history of renal transplantation.
• Patients receiving calcimimetic agents (e.g. cinacalcet / Sensipar) within 30 days of PTX.
• Patients currently taking lithium or with a history of lithium use.
• Pregnant patients

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (3)

University of Alabama-Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

University of California-Department of Surgery

San Francisco, California, 94143, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biospecimen samples will be obtained from FFPE tumor slides, Fresh-frozen tissue, and Blood. NOTE: Fresh-frozen tumor, normal gland biopsy and blood samples will be collected at the WUSM study site only.

MeSH Terms

Conditions

Parathyroid Neoplasms; Hyperparathyroidism, Primary

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Parathyroid Diseases; Hyperparathyroidism

Central Study Contacts

John A Olson, MD

CONTACT

(314) 362-8020; jaolsol@wustl.edu

Kathleen Harris

CONTACT

(314) 273-1433; harrisk@wustl.edu

Study Design

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

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 18, 2023
• Study Start: April 11, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

US (3)