Exploring molecular markers to predict treatment response in FH-deficient kidney cancer

Molecular Markers in Predicting Response to Treatment in FH-deficient RCC Patients

This study is testing if certain biological markers can help predict how well treatments will work for people with a rare and aggressive type of kidney cancer called FH-deficient RCC.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: RenJi Hospital (other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05535829 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients with fumarate hydratase-deficient renal cell carcinoma (FH-deficient RCC), a rare and aggressive subtype of kidney cancer. The study aims to identify molecular markers that can predict the effectiveness of systemic treatments, including immunotherapy and targeted therapy, in these patients. A total of 100 patients will be enrolled, and paired tissue and blood samples will be collected before and after the initiation of treatment to analyze these markers. The goal is to enhance personalized treatment strategies for advanced FH-deficient RCC.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histopathologically confirmed FH-deficient RCC who are scheduled to start their first cycle of systemic treatment.

Not a fit: Patients with other malignancies or those with active autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment strategies tailored to individual patients with FH-deficient RCC.

How similar studies have performed: While there is ongoing research in the field of biomarkers for cancer treatment, this specific approach to FH-deficient RCC is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. ≥18 years old;
2. histopathological evidence of FH-deficient RCC, which was confirmed by Sanger or next-generation sequencing after initial screening by IHC.
3. included patients must be diagnosed with metastatic renal cell carcinoma or have a TNM stage IV (according to 2009 TNM Classification);
4. new FH-deficient RCC patients who has scheduled to start 1st cycle of systemic treatment;
5. ECOG score ≤2;
6. life expectancy ≥ 3 months;
7. sign informed consent, and be able to follow the visit and related procedures stipulated in the program;
8. agree to collect tumor tissue, blood and other specimens required by this study and apply them to relevant studies;

Exclusion Criteria:

1. patients with other malignant tumors with different primary sites or histology from the tumor evaluated in this study within 2 years of personal history.
2. major surgery or severe trauma within 4 weeks before enrollment;
3. known or suspected active autoimmune diseases (congenital or acquired), such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroiditis, etc. Patients with type 1 diabetes with good insulin control can also be enrolled.
4. known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
5. allergic to any component of monoclonal antibody;
6. suffering from other uncontrolled serious diseases, including but not limited to: A) severe infection in the active phase or clinically poorly controlled; B) HIV infection (HIV antibody positive); C) acute or chronic active hepatitis b (HBsAg positive and HBV DNA\>1\*103/ml) or acute or chronic active hepatitis c (HCV antibody positive and HCV RNA\>15IU/ml); D) active tuberculosis, etc.;
7. class iii-iv congestive heart failure (New York heart association classification), poorly controlled and clinically significant arrhythmia;
8. uncontrolled arterial hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg);
9. pregnant or lactating women.

Where this trial is running

Shanghai, Shanghai

• Ethics Committee of Shanghai Renji Hospital — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Yunze Xu

Conditions: FH-Deficient RCC, Systemic Treatments, Biomarkers