1. Characterization of patients with persistent and recurrent primary hyperparathyroidism after at least one parathyroidectomy, with removal of at least one pathological parathyroid gland.2. Evaluation of pre-operative localization studies;…
ID
Source
Brief title
Condition
- Parathyroid gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Clinical and biochemical parameters
2. Pre-operative localization studies; MiBi-SPECT, PTH sampling
3. Intra-operative PTH measurements
4. Operative data
5. Pathology data
6. DNA analysis on leukocytes, formaline fixed paraffine imbedded (FFPE) tissue
or frozen material
Secondary outcome
No secondary study parameters
Background summary
In a pilot study of patients with recurrent or persistent PHPT we have observed
that they present with clinical characteristics clearly different from the
majority of patients with PHPT who achieve cure. They are younger, have a more
aggressive disease, with higher levels of serum calcium and PTH and more
complications, such as osteoporosis and nefrolithiasis. MiBi-scan is poorly
predictive of localization and intra-operative PTH has an abnormal pattern of
disappearance from the circulation. This represents the rationale for further
investigation of this group of patients compared with a control group of
patients with cured PHPT post-parathyroidectomy based on clinical, diagnostic,
pathological and genetic differentiating aspects of their disease.
Study objective
1. Characterization of patients with persistent and recurrent primary
hyperparathyroidism after at least one parathyroidectomy, with removal of at
least one pathological parathyroid gland.
2. Evaluation of pre-operative localization studies; SestaMiBi-SPECT scanning
and PTH sampling, in patients with recurrent/persistent PHPT vs cured control
patients.
3. Evaluation of intra-operative PTH measurements (IOPTH), in patients with
recurrent/persistent PHPT vs 5 year cured control patients.
4. Genetic characterization of patients with persistent/recurrent PHPT.
5. And in the process evaluate the real cure rate 1, 5 and 10 year after
parathyroidectomy in a control group.
Study design
single-centre, two fold design, retrospective data analysis from; previous
surgery, MiBi-SPECT, PTH sampling, IOPTH measurement, pathologic glands, and
prospective analysis; pedigree construction, DNA analysis, pathological
specification, simple blood analysis to ascertain the cure rate in recall
control patients.
Study burden and risks
No risks involved
Benefits: Decreased morbidity attached to a re-exploration by early
identification of patients with an increased risk of recurrence/persistence of
primary hyperparathyroidism after parathyroidectomy
Albunisdreef 2
2333 ZA
Nederland
Albunisdreef 2
2333 ZA
Nederland
Listed location countries
Age
Inclusion criteria
proven recurrent/persistent primary hyperparathyroidism after excision of one or more pathological parathyroid glands
Exclusion criteria
primary hyperparathyroidism due to MEN syndrome, lithium use or parathyroid carcinoma, secundary or tertiary (autonomous) hyperparathyroidism due to long time vitamin D deficiency or chronic renal failure
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL23097.058.08 |