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The real world research of thyroid dysfunction induced by PD-1 inhibitors and the establishment and prospective evaluation of the clinical thyroid dysfunction prediction model

The real world research of thyroid dysfunction induced by PD-1 inhibitors and the establishment and prospective evaluation of the clinical thyroid dysfunction prediction model

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300073798
Enrollment
Unknown
Registered
2023-07-21
Start date
2022-01-01
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

Patients with TD(Prospective section):N/A
Patients without TD(Prospective section):N/A
Case serise (Retrospective section):N/A

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Retrospective study part: ?Patients diagnosed tumor through pathological examination.?Patients received at least one dose of PD-1 inhibitor according to the standard protocol and continue PD-1 inhibitor therapy, the discontinuation indicates is disease progression or unacceptable toxicity or death. ?TD cannot be diagnosed before starting PD-1 treatment, the baseline values of fT3, fT4 and TSH are within the normal range, and TD related treatment drugs are not used.?General information, clinical diagnosis, treatment data and follow-up records are complete and available. Prospective study part: Match the criteria of inclusion ?-? of retrospective study part.

Exclusion criteria

Exclusion criteria: Retrospective study part: ?Patients without clear pathological diagnosis of tumor. ?Patients who discontinue or switch to another PD-1 inhibitors without indication. ? Patients who have been diagnosed as TD before starting PD-1 treatment, or any of the baseline values of fT3, fT4, and TSH is not within the normal range, or who have suffered from TD and are still receiving related treatment; ? Patient's general information, clinical diagnosis, treatment information and follow-up records are missing. Prospective study part: Match the criteria of exclusion ?-? of retrospective study part.

Design outcomes

Primary

MeasureTime frame
the occurrence of TD;

Secondary

MeasureTime frame
Clinical Characteristic and anticancer treatment;Blood routine, liver and kidney function, thyroid function;treatment response and survival;Protein markers;Model discrimination;Model calibration;Sensitivity ;Specificity;

Countries

China

Contacts

Public ContactTianlin Wang

Chinese PLA General Hospital

wangtl_301@126.com+86 10 6693 7226

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026