Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05932121
Other study ID # K4107-K23C1755
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 25, 2023
Est. completion date July 31, 2024

Study information

Verified date June 2023
Source Peking Union Medical College Hospital
Contact Qiaofei Liu, M.D
Phone 8615201693370
Email qfliu@aliyun.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

An observational cross-sectional case-control study on the postoperative quality of life (5 aspects, general quality of life, thyroid specific quality of life, scar appearance, voice and swallowing functions) of papillary thyroid carcinoma (PTC) patients underwent thyroid lobectomy via different approach, open vs trans-axillary. The patients are recruited in Peking Union Medical College Hospital (PUMCH) from 2020 to 2023 and are evaluated by follow-up with both outpatient visits and questionnaires made up of 9 validated scales.


Description:

Thyroid carcinoma is the most common thyroid tumor with a rising incidence. By 2015, it has risen to the fourth most common tumor among all tumors in female. Papillary thyroid carcinoma (PTC), representing up to 80% of all thyroid carcinomas, mostly occurring in female between 30-50 years old, although it has an excellent long-term survival outcome, still it brings the patients concerns and complaints of the obvious scars left on their necks by operations via traditional open approach. Cosmetic approaches of thyroid surgery have been developing rapidly in the last two decades, through approaches including trans-axillary, transoral, and trans-breast-chest, thyroid operations are able to avoid leaving surgical scars on the necks and instead leaving them on other parts of bodies covering by clothes. However, concerns of this new emerging technique including its excision extent, surgical complication, clinical outcome, functional outcome and postoperative quality of life still remain unsolved. Well-matched, high quality-studies focused on functional outcomes, cosmetic outcomes, and quality of life with large samples are still missing. This observational cross-sectional case-control study with follow-up on the postoperative quality of life, clinical outcomes, functional outcomes and cosmetic outcomes of PTC patients underwent thyroid lobectomy via different approach, open vs trans-axillary, aims on achieving comprehensive understanding on how different surgical approaches affect the quality of life, clinical outcomes and functional outcomes. Patients are recruited in PUMCH from 2020-2023 who underwent thyroid lobectomy and with a definite pathological diagnosis of PTC. Cases are defined as PTC patients who underwent thyroid lobectomy via trans-axillary approach. Controls are defined as PTC patients who underwent thyroid lobectomy via open approach. Controls are matched to cases with a 1:1 ratio according to gender, age, main operator. The postoperative quality of life, functional outcomes will be evaluated by a questionnaire made up of 4 validated scales (EORTC thyroid cancer specific quality of life questionnaire (THY34-QoL); patient scar assessment questionnaire (PSAQ); voice handicap index questionnaire (VHI-10); Swallowing impairment score (SIS-6). Clinical outcomes will be evaluated by data collected both from inpatient medical records and outpatient follow-up medical records. To our knowledge, this is the largest PTC thyroid lobectomy via trans-axillary approach case-control study worldwide, the first study with the design of assigning control matched to cases by applying pre-matching score method in this field, and the first study to concentrate on both clinical outcomes and comprehensive postoperative quality of life including physical, functional, and cosmetic outcomes in PTC patients via different surgical approaches.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date July 31, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - PTC patients underwent thyroid lobectomy with pathological diagnosis of PTC after surgery Exclusion Criteria: - Refusal to participate; Patients with invalid or incomplete questionnaire results; Patients with another primary malignancy; Patients with severe immune disease or chronic disease accompanying with major organ failure.

Study Design


Intervention

Procedure:
Thyroid lobectomy via trans-axillary approach
Patient with PTC underwent thyroid lobectomy via trans-axillary approach
Thyroid lobectomy via open approach
Patient with PTC underwent thyroid lobectomy via open approach

Locations

Country Name City State
China Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cosmetic outcomes The primary outcome will be evaluated by scores of cosmetic outcomes of PTC patients underwent thyroid lobectomy via different surgical approach up to 3 years after surgery. The scores are evaluated by a follow-up questionnaire made up of cosmetic outcome via scale of PSAQ. Scores will be compared in case and control groups. Lower scores in PSAQ indicate poorer outcomes in this field. up to 3 years after surgery
Secondary Thyroid cancer specific postoperative quality of life The thyroid cancer specific postoperative quality of life will be evaluated by scores of thyroid cancer specific quality of life of PTC patients underwent thyroid lobectomy via different surgical approach up to 3 years after surgery. The scores are evaluated by a follow-up questionnaire made up of EORTC THY34-QoL scale. Scores will be compared in case and control groups. Higher scores in EORTC THY34-QoL indicate better quality of life. up to 3 years after surgery
Secondary Voice outcomes The voice outcomes will be evaluated by scores of voice outcomes of PTC patients underwent thyroid lobectomy via different surgical approach up to 3 years after surgery. The scores are evaluated by a follow-up questionnaire made up of VHI-10 scale. Scores will be compared in case and control groups. Lower scores in VHI-6 indicate poorer outcomes in this field. up to 3 years after surgery
Secondary Swallowing function outcomes The swallowing function outcomes will be evaluated by scores of swallowing function outcome of PTC patients underwent thyroid lobectomy via different surgical approach up to 3 years after surgery. The scores are evaluated by a follow-up questionnaire made up of SIS-6 scale. Scores will be compared in case and control groups. Lower scores in SIS-6 indicate poorer outcomes in swallowing function. up to 3 years after surgery
Secondary Time to recurrence The time from the surgery to the recurrence (from date of surgery until the date of first documented recurrence including local recurrence, lymph node recurrence and distant metastasis). up to 3 years after surgery
See also
  Status Clinical Trial Phase
Recruiting NCT05774535 - Prospective, Observational Study on the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery
Withdrawn NCT04224792 - Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors N/A
Completed NCT01728623 - A Study of E7080 in Subjects With Advanced Thyroid Cancer Phase 2
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Completed NCT02911155 - Cancer and Other Disease Risks in U.S. Nuclear Medicine Technologists
Recruiting NCT05025046 - NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules
Not yet recruiting NCT03978351 - The Role of Midkine in Diagnosis of Thyroid Cancer
Completed NCT02658513 - Evaluation of Lancet Blood Sampling for Radioiodine Dosimetry in Thyroid Cancer
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Completed NCT02375451 - Effect of Childhood Radioiodine Therapy on Salivary Function N/A
Withdrawn NCT01994200 - Developing and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) for Thyroid Cancer Patients Phase 1/Phase 2
Terminated NCT01403324 - Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer N/A
Completed NCT00970359 - Reacquisition of Radioactive Iodine (RAI) Uptake of RAI-Refractory Metastatic Thyroid Cancers by Pretreatment With the Selective MEK Inhibitor AZD6244 N/A
Completed NCT00439478 - Dental Safety Profile of High-Dose Radioiodine Therapy Phase 4
Completed NCT00223158 - Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer N/A
Active, not recruiting NCT04544111 - PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer Phase 2
Completed NCT04876287 - Salivary dysfuncTion After Radioiodine Treatment
Recruiting NCT06073223 - Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer N/A
Recruiting NCT06037174 - Comparison of Quality of Life in Patients With Differentiated Thyroid Carcinoma Undergoing Different Surgery
Recruiting NCT04952493 - Anlotinib or Penpulimab in Combination With RAI for DTC Phase 2