- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Minya Governorate
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Minya, Minya Governorate, Egypten, 61611
- Faculty of Medicine
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde 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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: 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.
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Diagnosis of differentiated thyroid cancer: The presence of thyroid cancer was determined based on histopathological examination of the resected specimen
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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• Incidence of incidental differentiated thyroid cancer with autoimmune thyroiditis
Tidsramme: At time of surgery (postoperative histopathology)
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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)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of incidental differentiated thyroid cancer by autoimmune thyroiditis subtype
Tidsramme: At time of surgery
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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
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Outcome 3A: Age comparison
Tidsramme: At time of surgery
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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
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At time of surgery
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Outcome 3B: Sex distribution
Tidsramme: Preoperative (within 30 days before surgery)
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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
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Preoperative (within 30 days before surgery)
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Secondary Outcome 4 - Tumor characteristics Outcome 4A: Tumor size
Tidsramme: At time of surgery
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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
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At time of surgery
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Outcome 4B: Microcarcinoma proportion
Tidsramme: At time of surgery
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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
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At time of surgery
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Outcome 4C: Lymph node metastasis
Tidsramme: At time of surgery
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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
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At time of surgery
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Outcome 4D: Multifocality
Tidsramme: At time of surgery
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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)
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At time of surgery
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Outcome 3E: Extrathyroidal extension
Tidsramme: At time of surgery
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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)
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At time of surgery
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i det endokrine system
- Neoplasmer efter sted
- Neoplasmer
- Autoimmune sygdomme
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Thyroidneoplasmer
- Neoplasmer i endokrine kirtler
- Neoplasmer i hoved og hals
- Neoplasmer, kirtel og epitel
- Adenocarcinom
- Karcinom
- Skjoldbruskkirtelsygdomme
- Adenocarcinom, papillært
- Thyroiditis
- Kræft i skjoldbruskkirtlen, papillær
- Adenocarcinom, follikulær
- Hashimoto sygdom
- Thyreoiditis, autoimmun
Andre undersøgelses-id-numre
- 1462/02/2025
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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