RecruitingNot Applicable

The Effect of Serum Ferritin in irAE

China1,500 participantsStarted 2024-07-04

Plain-language summary

This is a prospective clinical study to clarify serum ferritin as a biomarker for the diagnosis, differential diagnosis and prognosis of immune-related adverse event(irAE).

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients voluntarily sign informed consent;
✓. The age was 18-75 years old, and the gender was not limited;
✓. Patients with definitive diagnosis of malignant solid tumor or acute leukemia;
✓. Patients enrolled in will be treated with immunotherapy (including immuno- monotherapy，or immuno- plus targeted therapy, or immuno- plus chemotherapy), or targeted therapy (including targeted monotherapy, or targeted plus chemotherapy), or chemotherapy.
✓. The Eastern Cooperative Oncology Group (ECOG) scored 0 or 1 or 2 for physical fitness;
✓. Sufficient bone marrow reserve at screening, defined as:
✓. The screening has appropriate organ function and meets the following criteria:
✓. The urine pregnancy test of women of childbearing age is negative. Any male and female patient with fertility must agree to use effective contraceptive methods during the whole study and at least 1 year after the study treatment.

Exclusion criteria

✕. Active systemic autoimmune disease is known before screening and is under treatment;
✕. Those who stopped systemic hormone therapy for less than 2 weeks before enrollment；
✕. Those who have received organ / tissue transplantation before screening;
✕. Those who meet any of the following conditions during screening:
✕. The heart meets any of the following conditions during screening:
✕. There are clinical emergencies (such as intestinal obstruction or vascular compression) requiring urgent treatment due to tumor body obstruction or compression during screening;
✕. Patients with active bleeding during screening;
✕. Patients with deep venous thrombosis or pulmonary embolism within 6 months before screening;

What they're measuring

calculated cut-off value for serum ferritin in the diagnosis of irAE

Timeframe: 1 year

Determining the sensitivity and specificity of serum ferritin in the diagnosis of irAE

Timeframe: 1 year

Determining baseline level of serum ferritin predicts irAE occurrence

Timeframe: 1 year

Trial details

NCT IDNCT06702566

SponsorTianjin Medical University Cancer Institute and Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-16

Contact for this trial

Liang Liu, M.D

86-22-23340123 liuliang@tjmuch.com

View on ClinicalTrials.gov More Immune-related Adverse Event trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients voluntarily sign informed consent;
✓. The age was 18-75 years old, and the gender was not limited;
✓. Patients with definitive diagnosis of malignant solid tumor or acute leukemia;
✓. Patients enrolled in will be treated with immunotherapy (including immuno- monotherapy，or immuno- plus targeted therapy, or immuno- plus chemotherapy), or targeted therapy (including targeted monotherapy, or targeted plus chemotherapy), or chemotherapy.
✓. The Eastern Cooperative Oncology Group (ECOG) scored 0 or 1 or 2 for physical fitness;
✓. Sufficient bone marrow reserve at screening, defined as:
✓. The screening has appropriate organ function and meets the following criteria:
✓. The urine pregnancy test of women of childbearing age is negative. Any male and female patient with fertility must agree to use effective contraceptive methods during the whole study and at least 1 year after the study treatment.

Exclusion criteria

✕. Active systemic autoimmune disease is known before screening and is under treatment;
✕. Those who stopped systemic hormone therapy for less than 2 weeks before enrollment；
✕. Those who have received organ / tissue transplantation before screening;
✕. Those who meet any of the following conditions during screening:
✕. The heart meets any of the following conditions during screening:
✕. There are clinical emergencies (such as intestinal obstruction or vascular compression) requiring urgent treatment due to tumor body obstruction or compression during screening;
✕. Patients with active bleeding during screening;
✕. Patients with deep venous thrombosis or pulmonary embolism within 6 months before screening;