- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07652450
Incidental Thyroid Cancer in Cases With Inflammatory Thyroid Lesion (Thyroid cancer)
Incidental Thyroid Cancer in Patients With Inflammatory Thyroid Lesions: A Cohort Study From a Tertiary Care Center
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Minya Governorate
-
Minya, Minya Governorate, Egypten, 61611
- Faculty of Medicine
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
All types of autoimmune thyroiditis, including:
- Graves' disease
- Toxic multinodular goiter (TMNG)
- Toxic nodule (TN)
- Hashimoto thyroiditis
- Unspecified toxic nodular goiter
- Age between 18 and 60 years
- Underwent thyroid surgical operation (lobectomy or total thyroidectomy)
Exclusion Criteria:
- Patients with known differentiated thyroid cancer before surgery
- Recurrent thyroid disease (previous thyroid surgery)
- Patients unfit for operation (American Society of Anesthesiologists grade IV or V)
- Incomplete histopathological data
- Patients with medullary thyroid carcinoma or anaplastic thyroid cancer
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Inflammatory thyroid lesions
The presence of thyroiditis was determined considering histological diagnosis taken post-surgery, and we considered the correlation between any presence of thyroiditis and all Differentiated thyroid cancer, taken from the histopathological examination after pathologic analysis.
|
Diagnosis of differentiated thyroid cancer: The presence of thyroid cancer was determined based on histopathological examination of the resected specimen
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
• Incidence of incidental differentiated thyroid cancer with autoimmune thyroiditis
Tidsram: At time of surgery (postoperative histopathology)
|
Title: Incidence of incidental differentiated thyroid cancer Unit of measure: % of patients (proportion) Metric/method: Histopathological examination of surgical specimen |
At time of surgery (postoperative histopathology)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of incidental differentiated thyroid cancer by autoimmune thyroiditis subtype
Tidsram: At time of surgery
|
Unit of Measure Percentage of patients within each subtype (Hashimoto thyroiditis, Graves' disease, toxic nodular goiter) Metric / Method Histopathological classification of thyroiditis subtype and cancer diagnosis; comparison using Chi-square test or Fisher's exact test |
At time of surgery
|
|
Outcome 3A: Age comparison
Tidsram: At time of surgery
|
Outcome Measure Title Mean age difference between patients with and without incidental differentiated thyroid cancer Unit of Measure Years (mean ± standard deviation) Metric / Method Unpaired Student's t-test or Mann-Whitney U test
|
At time of surgery
|
|
Outcome 3B: Sex distribution
Tidsram: Preoperative (within 30 days before surgery)
|
Field Entry Outcome Measure Title Proportion of patients with positive anti-thyroid peroxidase (anti-TPO) antibodies who have incidental differentiated thyroid cancer Unit of Measure Percentage of patients Metric / Method Serological testing (anti-TPO antibodies measured by immunoassay); Chi-square test or logistic regression for association
|
Preoperative (within 30 days before surgery)
|
|
Secondary Outcome 4 - Tumor characteristics Outcome 4A: Tumor size
Tidsram: At time of surgery
|
Outcome Measure Title Maximum tumor diameter in incidental differentiated thyroid cancers Unit of Measure Centimeters (mean ± standard deviation and range) Metric / Method Pathological measurement of surgical specimen
|
At time of surgery
|
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Outcome 4B: Microcarcinoma proportion
Tidsram: At time of surgery
|
Outcome Measure Title Proportion of incidental thyroid cancers that are microcarcinomas (≤1 cm) Unit of Measure Percentage of patients with incidental cancer Metric / Method Pathological measurement; defined as tumor size ≤1 cm
|
At time of surgery
|
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Outcome 4C: Lymph node metastasis
Tidsram: At time of surgery
|
Outcome Measure Title Proportion of patients with incidental differentiated thyroid cancer who have lymph node metastasis Unit of Measure Percentage of patients with incidental cancer Metric / Method Histopathological examination of central neck dissection specimens
|
At time of surgery
|
|
Outcome 4D: Multifocality
Tidsram: At time of surgery
|
Outcome Measure Title Proportion of patients with incidental differentiated thyroid cancer who have multifocal disease Unit of Measure Percentage of patients with incidental cancer Metric / Method Histopathological examination (two or more distinct tumor foci)
|
At time of surgery
|
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Outcome 3E: Extrathyroidal extension
Tidsram: At time of surgery
|
Outcome Measure Title Proportion of patients with incidental differentiated thyroid cancer who have extrathyroidal extension Unit of Measure Percentage of patients with incidental cancer Metric / Method Histopathological examination (minimal or extensive extension)
|
At time of surgery
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Sjukdomar i det endokrina systemet
- Neoplasmer efter plats
- Neoplasmer
- Autoimmuna sjukdomar
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Sköldkörtelneoplasmer
- Neoplasmer i endokrina körtel
- Neoplasmer i huvud och hals
- Neoplasmer, körtel och epitel
- Adenocarcinom
- Carcinom
- Sköldkörtelsjukdomar
- Adenocarcinom, papillärt
- Sköldkörtelinflammation
- Sköldkörtelcancer, papillär
- Adenocarcinom, follikulärt
- Hashimoto sjukdom
- Tyreoidit, autoimmun
Andra studie-ID-nummer
- 1462/02/2025
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