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Thyroid DiseasesTHORSNCT07812779

Thyroid Health Outcomes Registry for Surgery

An observational study of Thyroid Diseases and Thyroid Neoplasms, run by Pirogov Russian National Research Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

THORS is a single-center ambidirectional observational cohort study conducted at Moscow Multidisciplinary Clinical Center "Kommunarka". The study combines retrospective analysis of routinely collected clinical data from patients who underwent thyroid surgery beginning in January 2023 with ongoing prospective accrual… Read more about this study

Who is it for?
Ages 18 years and older
How many people
3,000 participants
Where
No sites listed yet
Study dates
1 Sep 2026to 31 Jan 2032
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients treated surgically for benign or malignant thyroid disease at a single multidisciplinary medical center in Moscow. The population is identified from routine clinical-care data and includes historical patients as well as newly accrued eligible patients. Primary, completion, and repeat thyroid operations are eligible when the relevant data can be linked and the episode meets the specific substudy requirements.

Who may be able to join

  • Patient undergoes or previously underwent an operation involving the thyroid gland at the study institution during the study period.
  • The operation was performed for a benign or malignant thyroid disease, including primary, completion, or repeat thyroid surgery.
  • Source data permit linkage of the patient, hospitalization, operation, and index date.
  • For a specific substudy, the participant/episode meets the additional prespecified requirements for the relevant exposure and outcome.

Who cannot join

  • Procedure predominantly involving the parathyroid glands without a confirmed relationship to thyroid disease.
  • Procedure or record without a confirmed relationship to thyroid disease.
  • Technical duplicate record.
  • Episode for which the essential temporal sequence or index date cannot be established for the relevant analysis.
  • Record lacking the minimum data required to determine the primary outcome of the specific substudy.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Sergey V. Mosin, PhD contact

+79163790717

mosin-sergey@yandex.ru

About this study

Official title: Comprehensive Analysis of Quality and Outcomes in Thyroid Surgery Using Real-World Clinical Data

THORS is a single-center ambidirectional observational cohort study conducted at Moscow Multidisciplinary Clinical Center "Kommunarka". The study combines retrospective analysis of routinely collected clinical data from patients who underwent thyroid surgery beginning in January 2023 with ongoing prospective accrual of new eligible patients and longitudinal updating of follow-up information. No diagnostic or therapeutic intervention is assigned by the research protocol; all treatment decisions are made as part of routine clinical care. The program evaluates the structure and outcomes of thyroid surgery, postoperative complications, histopathology, repeat and completion procedures, long-term oncologic and functional outcomes, health-care resource use, and the quality and reproducibility of real-world data. Applicable outcomes from the international Core Outcome Set for surgical treatment of differentiated thyroid carcinoma (COS-DTC) are incorporated where they can be reliably measured. The first frozen historical analytical baseline includes 968 unique patients and 1,017 thyroid operations performed from 06 January 2023 through 13 February 2026. The cohort remains open to ongoing enrollment and follow-up

Read the detailed description

THORS is an umbrella real-world-data research program designed as an open, single-center, ambidirectional observational cohort. The historical component uses secondary data generated during routine care, including operative records, hospitalizations, pathology and immunohistochemistry reports, inpatient and outpatient clinical documentation, repeat admissions, follow-up encounters, and available resource/cost information. After registration, new eligible patients continue to enter the cohort prospectively as part of ordinary clinical practice, and clinically available follow-up information is added longitudinally. The research protocol does not assign the type or extent of thyroid surgery, lymph-node dissection, diagnostic testing, or adjuvant treatment.

The program uses linked patient-, hospitalization-, operation-, pathology-, complication-, and follow-up-level data structures. Raw source values, technically normalized data, automated screening signals, author clinical classification, independent expert classification, and adjudicated values are retained as separate layers whenever applicable. Each substantive substudy has a prespecified scientific question, eligibility criteria, outcome definitions, data freeze, and statistical analysis plan. Missingness, source provenance, discordance between data sources, classification error, and repeated observations within patients are explicitly evaluated.

Clinical objectives include description of surgical practice and pathology; clinically verified postoperative complications; functional outcomes; repeat, completion, and recurrence-related surgery; long-term oncologic outcomes; comparisons of clinically relevant surgical strategies when adequate confounding control is possible; and health-care resource use. Methodological objectives include reproducibility of cohort construction and phenotyping, multi-source detection and expert adjudication of outcomes, data-quality assessment, and the feasibility of measuring the 13 COS-DTC outcomes in routine data.

The historical cohort predates registration. Analyses already completed or initiated on historical data are treated as retrospective baseline analyses and are not represented as prospectively registered. Future substudies are date-stamped through protocol/SAP versions and frozen analytical datasets. The complete prespecified THORS research portfolio is listed in Appendix A of this registration dossier, including methodological, clinical, prognostic, comparative, economic, specialized, long-term, and transferability studies. Prospective questionnaires, research-only biospecimen collection, or additional study-specific procedures require the relevant ethics approval and, when they materially change the registered protocol, an amendment or a separate registration record.

Keywords
thyroid surgery, endocrine surgery, thyroidectomy, hemithyroidectomy, completion thyroidectomy, cervical lymph node dissection, thyroid cancer, differentiated thyroid carcinoma, medullary thyroid carcinoma, postoperative complications, real-world data, RWD, observational cohort, data quality, clinical phenotyping, COS-DTC
Medical subject headings
Thyroid Diseases, Thyroid Neoplasms, Thyroid Nodule, Goiter, Carcinoma, Medullary, Adrenal Gland Neoplasms, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07812779
Study groupRoleWhat they receive
Patients Undergoing Thyroid SurgeryPatients undergoing surgery involving the thyroid gland for benign or malignant thyroid disease at Moscow Multidisciplinary Clinical Center "Kommunarka". The cohort includes primary, completion, and repeat operations and is updated as new eligible patients and follow-up information become available. Routine-care thyroid surgery. The type and extent of surgery are determined by the treating clinical team according to routine care and are not assigned by the research protocol. Procedures may include hemithyroidectomy, thyroidectomy, completion thyroidectomy, repeat thyroid surgery, central and/or lateral cervical lymph-node dissection, and other clinically indicated thyroid-related procedures. No protocol-assigned comparator. Comparisons between naturally occurring clinical strategies may be performed in prespecified observational substudies with appropriate control of confounding and assessment of positivity.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinically Verified 30-Day Postoperative Complication Rate

    Proportion of index thyroid operations followed by at least one clinically verified postoperative complication within 30 days, using prespecified event definitions, multiple routine-care sources where available, and expert adjudication. Complication types are reported separately and may include hypocalcemia/hypoparathyroidism, recurrent laryngeal nerve dysfunction, hematoma/bleeding, infection, chyle leak, unplanned reoperation, organ injury, readmission, and other clinically relevant events.

    Measured: Within 30 days after each index thyroid operation

  2. Percentage of Participants With an Unplanned Reoperation Related to Thyroid Surgery Within 30 Days

    The number of unique participants who undergo at least one unplanned surgical reoperation related to the index thyroid operation within 30 days will be divided by the number of participants with ascertainable 30-day follow-up and multiplied by 100. Planned completion thyroidectomy is classified separately and is not counted as an unplanned reoperation.

    Measured: Up to 30 days after the index thyroid operation

Secondary outcomes (13)
  1. 30-Day Mortality

    All-cause death within 30 days of the index thyroid operation, using available in-hospital and post-discharge sources.

    Measured: Within 30 days after index thyroid surgery

  2. Permanent Recurrent Laryngeal Nerve Palsy Due to Surgery

    Persistent postoperative vocal-fold dysfunction attributable to surgery at 12 months, with preoperative dysfunction, tumor invasion, and intentional nerve resection considered separately.

    Measured: 12 months after the index operation

  3. Permanent Postoperative Hypoparathyroidism

    Persistent postoperative parathyroid dysfunction at 12 months based on prespecified biochemical and treatment criteria.

    Measured: 12 months after the index operation

  4. Percentage of Index Operations in Each Final Histopathologic Diagnosis Category

    Among index operations with a valid final pathology report, the number of operations assigned to each prespecified mutually exclusive diagnosis category will be divided by the total number of operations with valid final pathology and multiplied by 100. Categories are differentiated thyroid carcinoma, medullary thyroid carcinoma, other malignant thyroid neoplasm, benign thyroid neoplasm, non-neoplastic thyroid disease, and other or indeterminate pathology.

    Measured: Up to 90 days after the index thyroid operation

  5. Percentage of Participants With Persistent Differentiated Thyroid Carcinoma at 12 Months

    Among participants with differentiated thyroid carcinoma and an ascertainable 12-month assessment, the number meeting the prespecified definition of structural or biochemical persistent disease at 12 months will be divided by the total number with an ascertainable assessment and multiplied by 100. A participant is counted once if either the structural or biochemical persistence criterion is met.

    Measured: 12 months after the index thyroid operation

  6. Percentage of Index Operations in Each Mutually Exclusive Thyroid Resection Category

    The number of index operations assigned to each prespecified mutually exclusive thyroid resection category will be divided by the total number of eligible index operations and multiplied by 100. Categories are hemithyroidectomy, initial total thyroidectomy, completion thyroidectomy, and other thyroid resection.

    Measured: During the index thyroid operation

  7. Median Available Direct Medical Cost of the Index Hospitalization

    Available direct medical cost for the index thyroid-surgery hospitalization will be summarized as the median with interquartile range in Russian rubles among hospitalizations with recorded cost data. Structurally unavailable cost values will be reported as missing and will not be automatically imputed.

    Measured: During the index hospitalization, from admission through discharge, up to 60 days

  8. Percentage of Operations in Each Standardized Pathologic T Category

    Among operations with morphologically confirmed primary thyroid carcinoma and an ascertainable pathologic T category, the number of operations in each standardized pT category will be divided by the total number of operations with an ascertainable pT category and multiplied by 100. The pT category is derived from the final pathology report using the prespecified staging rules.

    Measured: Up to 90 days after the index thyroid operation

  9. Percentage of Operations in Each Standardized Pathologic N Category

    Among operations with morphologically confirmed primary thyroid carcinoma and an ascertainable pathologic N category, the number of operations in each standardized pN category will be divided by the total number of operations with an ascertainable pN category and multiplied by 100. The pN category is derived from the final pathology report using the prespecified staging rules.

    Measured: Up to 90 days after the index thyroid operation

  10. Percentage of Participants With a New Recurrence of Differentiated Thyroid Carcinoma

    Among participants with differentiated thyroid carcinoma who have no evidence of persistent disease after initial treatment, the number who develop a new structural or biochemical recurrence will be divided by the number with evaluable follow-up and multiplied by 100. A participant is counted once if either the structural or biochemical recurrence criterion is met.

    Measured: Up to 5 years after the index thyroid operation

  11. Percentage of Index Operations With Central Neck Lymph Node Dissection

    The number of eligible index thyroid operations that include a central neck lymph node dissection will be divided by the total number of eligible index thyroid operations and multiplied by 100. Central and lateral neck dissections are classified separately according to the prespecified operation-classification rules.

    Measured: During the index thyroid operation

  12. Percentage of Index Operations With Lateral Neck Lymph Node Dissection

    The number of eligible index thyroid operations that include a lateral neck lymph node dissection will be divided by the total number of eligible index thyroid operations and multiplied by 100. Central and lateral neck dissections are classified separately according to the prespecified operation-classification rules.

    Measured: During the index thyroid operation

  13. Percentage of Participants Undergoing Planned Completion Thyroidectomy Within 12 Months

    Among participants who undergo an initial hemithyroidectomy and are eligible for longitudinal trajectory assessment, the number who subsequently undergo a planned completion thyroidectomy within 12 months will be divided by the number with ascertainable 12-month surgical follow-up and multiplied by 100. Planned completion surgery is not classified as an unplanned reoperation.

    Measured: Up to 12 months after the initial hemithyroidectomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion31 Jan 2032 (estimated)
  4. Study completion31 Jan 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
3,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07812779
Sponsor's protocol ID
THORS
Acronym
THORS
Status last verified
Sep 2026
First submitted
1 Sep 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: in accordance with national requirements for the security and protection of personal data

Questions about this trial

What is this clinical trial studying?

An observational study of Thyroid Diseases and Thyroid Neoplasms, run by Pirogov Russian National Research Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sergey V. Mosin, PhD (+79163790717, mosin-sergey@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinically Verified 30-Day Postoperative Complication Rate (time frame: Within 30 days after each index thyroid operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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