MetabolomicsNCT05243173
Biomarkers of Response to Systemic Treatments in FH-deficient RCC
An observational study of Metabolomics and Renal Cell Carcinoma, run by RenJi Hospital at 1 site in China.
Trial summary
Fumarate hydratase-deficient renal cell carcinoma (FH-deficient RCC) is a rare subtype of RCC characterized by germline/somatic mutation of the fumarate hydratase (FH) gene, and is an extremely aggressive tumor, with a propensity to disseminate early even in the setting of a small primary tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolomics, Renal Cell Carcinoma, FH-Deficient RCC
- What is being tested?
- Sequencing
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2022to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with FH-RCC who have given prior consent for their samples and data to be used, and who have adequate samples and data available.
Who may be able to join
- ≥18 years old;
- histopathological evidence of FH-deficient renal cell carcinoma, which was confirmed by Sanger or next-generation sequencing after initial screening by IHC.
- included patients must be diagnosed with metastatic renal cell carcinoma or have a TNM stage IV (according to 2009 TNM Classification);
- new FH-RCC patients who has scheduled to start 1st cycle of systemic treatment;
- ECOG score ≤2;
- life expectancy ≥ 3 months;
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- sign informed consent, and be able to follow the visit and related procedures stipulated in the program;
- agree to collect tumor tissue, blood and other specimens required by this study and apply them to relevant studies;
- Patients must have consent in place, for the use of tissue and imaging to be used for the purposes of clinical research; Use of tissue not required for their diagnosis or treatment to be stored and used for the purposes of clinical research, which may include genetic research. Use of relevant sections of their medical records, or by relevant regulatory authorities, where my tissue is being used for research, giving permission for those individuals to have access to their medical records. Participants must also meet at least one of the following criteria to be eligible: For tissue analysis: Patient must have tumour tissue and/or normal adjacent kidney stored (either as formalinfixed paraffin-embedded tissue, or as 'fresh frozen' tissue). For imaging analysis: Patient must have had at least 1 scan (either CT or MRI) within 28 days of starting treatment with systemic treatment for their cancer.
Who cannot join
- patients with other malignant tumors with different primary sites or histology from the tumor evaluated in this study within 2 years of personal history, except those with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or cervical carcinoma in situ under good control;
- major surgery or severe trauma within 4 weeks before enrollment;
- 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.
- known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- allergic to any component of monoclonal antibody;
- 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.;
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- class iii-iv congestive heart failure (New York heart association classification), poorly controlled and clinically significant arrhythmia;
- uncontrolled arterial hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg);
- pregnant or lactating women.
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yunze Xu
Shanghai, 200127
Yunze Xu, +8618801967501, rjxuyunze@163.com
About this study
Official title: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Fumarate hydratase-deficient renal cell carcinoma (FH-deficient RCC) is a rare subtype of RCC characterized by germline/somatic mutation of the fumarate hydratase (FH) gene, and is an extremely aggressive tumor, with a propensity to disseminate early even in the setting of a small primary tumor.
Affected individuals or individuals suspected of having a germline FH will undergo periodic clinical assessment and genetic analyses for the purpose of: 1) definition and characterization of phenotype, 2) determination of the natural history of the disorder, and 3) genotype/phenotype correlation. Genetic linkage studies may be performed in situations in which the genetic basis of the disorder has not been elucidated.
Read the detailed description
- Discovery and validation of biomarker predicting FH-deficient RCC systemic treatments response
- Analysis for expression level of ctDNA using Next generation sequencing in FH-deficient RCC blood by systemic treatments response
- Analysis for expression level of mRNA using Next generation sequencing in FH-deficient RCC tissue by systemic treatments response
- Analysis for expression level of small molecule metabolites using mass spectrometry in FH-deficient RCC tissue and blood by systemic treatments response
- Analysis for genetic and protein expression at a single-cell level using a novel flow cytometry and RNA-sequencing protocol in FH-deficient RCC tissue and blood.
- Validation of genetic and protein expression using qRT-PCR or IHC in multiple independent cohort.
- Biological biomarkers-clinical factor combined prediction model of FH-deficient RCC systemic treatments response
- Being tested
- Sequencing
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SequencingOther
Laboratory analysis of samples
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomics
across multiple LC-MS data files. across multiple LC-MS data files. across multiple LC-MS data files. across multiple LC-MS data files. across multiple LC-MS data files
Measured: 2 years
Determine genotype/phenotype correlations
Collection of blood, tissue \& urine to address further scientific questions related to this protocol.
Measured: 3 years
Discovery of predicting bio-markers for FH-deficient RCC systemic treatments response
Combination prediction model of biologic biomarkers and clinical factors for the response of systemic treatments in FH-RCC.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start25 May 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetabolomicsStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243173
- Sponsor's protocol ID
- RJFHRCC
- Status last verified
- Aug 2022
- First submitted
- 20 Dec 2021
- Last updated
- 16 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renji Hospital, School of Medicine, Shanghai Jiao Tong University
- ClinicalTrials.gov ID
- NCT05243173
- Acronym / sponsor ID
- RJFHRCC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fumarate hydratase-deficient renal cell carcinoma (FH-deficient RCC) is a rare subtype of RCC characterized by germline/somatic mutation of the fumarate hydratase (FH) gene, and is an extremely aggressive tumor, with a propensity to disseminate early even in the setting of a small primary tumor.
Affected individuals or individuals suspected of having a germline FH will undergo periodic clinical assessment and genetic analyses for the purpose of: 1) definition and characterization of phenotype, 2) determination of the natural history of the disorder, and 3) genotype/phenotype correlation. Genetic linkage studies may be performed in situations in which the genetic basis of the disorder has not been elucidated.
Detailed description
- Discovery and validation of biomarker predicting FH-deficient RCC systemic treatments response
- Analysis for expression level of ctDNA using Next generation sequencing in FH-deficient RCC blood by systemic treatments response
- Analysis for expression level of mRNA using Next generation sequencing in FH-deficient RCC tissue by systemic treatments response
- Analysis for expression level of small molecule metabolites using mass spectrometry in FH-deficient RCC tissue and blood by systemic treatments response
- Analysis for genetic and protein expression at a single-cell level using a novel flow cytometry and RNA-sequencing protocol in FH-deficient RCC tissue and blood.
- Validation of genetic and protein expression using qRT-PCR or IHC in multiple independent cohort.
- Biological biomarkers-clinical factor combined prediction model of FH-deficient RCC systemic treatments response
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with FH-RCC who have given prior consent for their samples and data to be used, and who have adequate samples and data available.
Key inclusion criteria (9 listed)
- ≥18 years old;
- histopathological evidence of FH-deficient renal cell carcinoma, which was confirmed by Sanger or next-generation sequencing after initial screening by IHC.
- included patients must be diagnosed with metastatic renal cell carcinoma or have a TNM stage IV (according to 2009 TNM Classification);
- new FH-RCC patients who has scheduled to start 1st cycle of systemic treatment;
- ECOG score ≤2;
Key exclusion criteria (10 listed)
- patients with other malignant tumors with different primary sites or histology from the tumor evaluated in this study within 2 years of personal history, except those with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or cervical carcinoma in situ under good control;
- major surgery or severe trauma within 4 weeks before enrollment;
- 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.
- known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- allergic to any component of monoclonal antibody;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SequencingLaboratory analysis of samples | Other | – |
Primary outcome
Metabolomics
Time frame: 2 years
across multiple LC-MS data files. across multiple LC-MS data files. across multiple LC-MS data files. across multiple LC-MS data files. across multiple LC-MS data files
Determine genotype/phenotype correlations
Time frame: 3 years
Collection of blood, tissue \& urine to address further scientific questions related to this protocol.
Discovery of predicting bio-markers for FH-deficient RCC systemic treatments response
Time frame: 3 years
Combination prediction model of biologic biomarkers and clinical factors for the response of systemic treatments in FH-RCC.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolomics and Renal Cell Carcinoma, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomics (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.