Clinical trial NCT06195228: A Retrospective and Prospective Real-world Study of Molecular Typing in the Treatment of Advanced Thyroid Cancer
Official title: A Retrospective and Prospective Real-world Study of Molecular Typing in the Treatment of Advanced Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Advanced Thyroid Cancer Patients Who Received Target Therapy
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Inner Mongolia Cancer Hospital Affiliated To Inner Mongolia Medical University
name: Shanxi Province Cancer Hospital
First posted: 2024-01-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a retrospective and prospective real-world clinical study of molecular typing in the treatment of advanced thyroid cancer.

The retrospective study : Patients with advanced thyroid cancer who received precise treatment in our hospital from January 2020 to December 2023 were retrieved. The number of previous treatment lines was not limited. Patients who met the inclusion criteria were screened according to the inclusion and exclusion criteria. Demographic information, clinical characteristics, tumor treatment history, medication regimen, adverse reactions, molecular test results, survival follow-up results and other data were collected.

The prospective study : Patients with advanced thyroid cancer who received precise treatment in our hospital from January 2024 to April 2027 were enrolled.


Eligibility criteria: Inclusion Criteria:

1. Patients volunteered to participate in this study and signed informed consent;
2. Age: ≥ 18 years old, male or female;
3. Histologically diagnosed locally advanced or recurrent / metastatic thyroid cancer that cannot undergo radical surgery meets one of the following requirements:

   1. Radioiodine-refractory thyroid cancer;
   2. Differentiated thyroid carcinoma not suitable for iodine therapy;
   3. Medullary thyroid carcinoma;
   4. High-grade or poorly differentiated thyroid cancer;
   5. Anaplastic thyroid cancer;
4. Patients who had undergone NGS testing (in our hospital or other hospitals) were able to query the test report or the key genetic test results recorded in the medical history (such as BRAF, RET, NTRK and other genetic test results).

Exclusion Criteria:

1. Patients who are participating in clinical trials of other drugs;
2. There is evidence that the patients are pregnant or lactating;
3. Other situations that are not suitable for inclusion in this study.

Primary outcomes:
measure: Objective Response Rate(ORR)
timeFrame: up to approximately 3 years
Secondary outcomes:
measure: Duration of Response(DOR)
timeFrame: up to approximately 3 years
measure: Disease Control Rate(DCR)
timeFrame: up to approximately 3 years
measure: Time to response(TTR)
timeFrame: up to approximately 3 years
measure: Progression Free Survival(PFS)
timeFrame: up to approximately 3 years
measure: Overall survival(OS)
timeFrame: up to approximately 3 years
Other outcomes:
Locations:
city: Hohhot
country: China
facility: Caixia Liu
state: Inner Mongolia
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanxi
country: China
facility: Shanxi Cancer Hospital
state: Taiyuan
Study officials:
affiliation: Fudan University
name: Dongmei Ji, M.D
role: PRINCIPAL_INVESTIGATOR
References: