- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Minya Governorate
-
Minya, Minya Governorate, Egypt, 61611
- Faculty of Medicine
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
• Incidence of incidental differentiated thyroid cancer with autoimmune thyroiditis
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of incidental differentiated thyroid cancer by autoimmune thyroiditis subtype
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
|
Outcome 4B: Microcarcinoma proportion
Tidsramme: 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
|
|
Outcome 4C: Lymph node metastasis
Tidsramme: 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
Tidsramme: 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
|
|
Outcome 3E: Extrathyroidal extension
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i det endokrine systemet
- Neoplasmer etter nettsted
- Neoplasmer
- Autoimmune sykdommer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer i skjoldbruskkjertelen
- Neoplasmer i endokrine kjertel
- Neoplasmer i hode og nakke
- Neoplasmer, kjertel og epitel
- Adenokarsinom
- Karsinom
- Skjoldbrusk sykdommer
- Adenokarsinom, papillært
- Skjoldbruskbetennelse
- Kreft i skjoldbruskkjertelen, papillær
- Adenokarsinom, follikulær
- Hashimoto sykdom
- Tyreoiditt, autoimmun
Andre studie-ID-numre
- 1462/02/2025
Plan for individuelle deltakerdata (IPD)
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