Complicated Adrenal Tumor DiseasesNCT04529629
Precise Diagnosis, Treatment and Prognostic Evaluation of Complicated Adrenal Tumor Diseases
An observational study of Complicated Adrenal Tumor Diseases, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The adrenal gland is an important organ that produces life hormones. There are many types of adrenal tumors, which tend to occur in young adults and affect the whole body. It has the dual threat: hormone secretion and tumor metastasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Complicated Adrenal Tumor Diseases
- What is being tested?
- surgery or drug
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2021to 30 Aug 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion Criteria: * Age ≥ 18 years old and ≤ 75 years * Diagnosis of Patients with primary aldosteronism, pheochromocytoma, and cortical cancer * Gender: males and females * Provide written informed consent * Satisfactory compliance Exclusion Criteria: 1. Patients with renal insufficiency (Cr>2 times the upper limit of normal). 2. Patients with a history of liver cirrhosis. 3. Patients who are currently using corticosteroids. 4. Patients with cardiac insufficiency (NYHA cardiac function classification grade 3 and above or EF<50%). 5. Patients with stroke and acute myocardial infarction in the past 6 months. 6. Patients during pregnancy and lactation
Who may be able to join
- Age ≥ 18 years old and ≤ 75 years
- Diagnosis of Patients with primary aldosteronism, pheochromocytoma, and cortical cancer
- Gender: males and females
- Provide written informed consent
- Satisfactory compliance
Who cannot join
- Patients with renal insufficiency (Cr>2 times the upper limit of normal).
- Patients with a history of liver cirrhosis.
- Patients who are currently using corticosteroids.
- Patients with cardiac insufficiency (NYHA cardiac function classification grade 3 and above or EF<50%).
- Patients with stroke and acute myocardial infarction in the past 6 months.
- Patients during pregnancy and lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Yiran Jiang
About this study
The adrenal gland is an important organ that produces life hormones. There are many types of adrenal tumors, which tend to occur in young adults and affect the whole body. It has the dual threat: hormone secretion and tumor metastasis. At present, there are four major dilemmas in the clinical diagnosis and treatment of adrenal tumors: 1) Pulse secretion of the hormones, which are affected by many factors; and the diagnostic value of single hormone is limited; 2) Traditional imaging cannot accurately reflect the characteristics of hormone secretion. The prognosis cannot be accurately predicted; 3) The molecular characteristics of tumor cells and the microenvironment are unclear, making it difficult to implement early diagnosis and precise treatment; 4) Traditional pathology cannot determine the nature and long-term prognosis of the tumor, which makes the treatment delay, and the disease prognosis is extremely poor. It threatens the lives of patients.
Starting from solving the above-mentioned key problems in the early stage, the research team has systematically established new clinical diagnostic technologies, hormone dynamic tests to accurately assess hormone secretion and segmented blood collection hormone determination technologies to accurately locate adrenal tumors; A series of important research results have been published in Science, Lancet Diabetes \& Endocrinology, Cell Research, etc To sum up, the goal of this research is improving the early diagnosis rate of complicated adrenal tumors especially in malignant tumors, developing the optimal treatment plan, avoiding unnecessary surgical treatment, improving the quality of life of patients, reducing mortality. This project will further integrate the adrenal cortex and medulla hormone mass spectrometry detection and the molecular markers of adrenal tumors through phenotypic, functional imaging, and molecular pathological evaluations, and built a sensitive drug screening platform that integrates visual drug response and molecular characteristics, thereby achieving precise diagnosis and treatment of complicated adrenal tumors.
- Conditions
- Complicated Adrenal Tumor Diseases
- Being tested
- surgery or drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery or drugOther
pheochromocytoma and adrenocortical carcinoma need surgery and primary aldosteronism need drug according to the genetic results
| Study group | Role | What they receive |
|---|---|---|
| primary aldosteronism | Not described Receives: Other: surgery or drug | |
| pheochromocytoma | Not described Receives: Other: surgery or drug | |
| adrenocortical carcinoma | Not described Receives: Other: surgery or drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor biochemical marker treatment response
- Complete remission (normalization of tumor markers);
- Partial remission (reduction of tumor markers ≥ 50%); ③No change (decrease of tumor markers <50% or increase ≤25%); ④Disease progression (tumor markers increased> 25%).
Measured: 20 years
Tumor volume assessment: According to RECIST (version 1.1).
- Complete response: All target lesions disappear, and the short axis of any pathological lymph nodes must be reduced to <10 mm.
- Partial Response: The total diameter of the target lesions is reduced by at least 30% compared with the baseline.
- Progressive Disease: Take the minimum value of the sum of the diameters of all target lesions measured during the study as the reference, and the relative increase in diameter sum by at least 20% ④Stable Disease: Based on the minimum value of the sum of the diameters of all target lesions measured during the study, the reduction of the target lesion did not reach PR, and the degree of increase did not reach PD, between PR and PD.
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start30 Aug 2021
- Primary completion30 Aug 2040 (estimated)
- Study completion30 Aug 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Adrenal Tumor DiseasesStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Weiqing, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529629
- Sponsor's protocol ID
- CCEMD-2020-0825
- Status last verified
- Dec 2021
- First submitted
- 24 Aug 2020
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- 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 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precise Diagnosis, Treatment and Prognostic Evaluation of Complicated Adrenal Tumor Diseases
- ClinicalTrials.gov ID
- NCT04529629
- Acronym / sponsor ID
- CCEMD-2020-0825
- Conditions
- Complicated Adrenal Tumor Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 30 Aug 2040 (estimated)
- Study completion
- 30 Aug 2041 (estimated)
- First posted
- 27 Aug 2020 (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.
The adrenal gland is an important organ that produces life hormones. There are many types of adrenal tumors, which tend to occur in young adults and affect the whole body. It has the dual threat: hormone secretion and tumor metastasis. At present, there are four major dilemmas in the clinical diagnosis and treatment of adrenal tumors: 1) Pulse secretion of the hormones, which are affected by many factors; and the diagnostic value of single hormone is limited; 2) Traditional imaging cannot accurately reflect the characteristics of hormone secretion. The prognosis cannot be accurately predicted; 3) The molecular characteristics of tumor cells and the microenvironment are unclear, making it difficult to implement early diagnosis and precise treatment; 4) Traditional pathology cannot determine the nature and long-term prognosis of the tumor, which makes the treatment delay, and the disease prognosis is extremely poor. It threatens the lives of patients.
Starting from solving the above-mentioned key problems in the early stage, the research team has systematically established new clinical diagnostic technologies, hormone dynamic tests to accurately assess hormone secretion and segmented blood collection hormone determination technologies to accurately locate adrenal tumors; A series of important research results have been published in Science, Lancet Diabetes \& Endocrinology, Cell Research, etc To sum up, the goal of this research is improving the early diagnosis rate of complicated adrenal tumors especially in malignant tumors, developing the optimal treatment plan, avoiding unnecessary surgical treatment, improving the quality of life of patients, reducing mortality. This project will further integrate the adrenal cortex and medulla hormone mass spectrometry detection and the molecular markers of adrenal tumors through phenotypic, functional imaging, and molecular pathological evaluations, and built a sensitive drug screening platform that integrates visual drug response and molecular characteristics, thereby achieving precise diagnosis and treatment of complicated adrenal tumors.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| primary aldosteronism | – | Other: surgery or drug |
| pheochromocytoma | – | Other: surgery or drug |
| adrenocortical carcinoma | – | Other: surgery or drug |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion Criteria: * Age ≥ 18 years old and ≤ 75 years * Diagnosis of Patients with primary aldosteronism, pheochromocytoma, and cortical cancer * Gender: males and females * Provide written informed consent * Satisfactory compliance Exclusion Criteria: 1. Patients with renal insufficiency (Cr>2 times the upper limit of normal). 2. Patients with a history of liver cirrhosis. 3. Patients who are currently using corticosteroids. 4. Patients with cardiac insufficiency (NYHA cardiac function classification grade 3 and above or EF<50%). 5. Patients with stroke and acute myocardial infarction in the past 6 months. 6. Patients during pregnancy and lactation
Key inclusion criteria (5 listed)
- Age ≥ 18 years old and ≤ 75 years
- Diagnosis of Patients with primary aldosteronism, pheochromocytoma, and cortical cancer
- Gender: males and females
- Provide written informed consent
- Satisfactory compliance
Key exclusion criteria (6 listed)
- Patients with renal insufficiency (Cr>2 times the upper limit of normal).
- Patients with a history of liver cirrhosis.
- Patients who are currently using corticosteroids.
- Patients with cardiac insufficiency (NYHA cardiac function classification grade 3 and above or EF<50%).
- Patients with stroke and acute myocardial infarction in the past 6 months.
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 |
|---|---|---|
| surgery or drugpheochromocytoma and adrenocortical carcinoma need surgery and primary aldosteronism need drug according to the genetic results | Other | adrenocortical carcinoma, pheochromocytoma, primary aldosteronism |
Primary outcome
tumor biochemical marker treatment response
Time frame: 20 years
* Complete remission (normalization of tumor markers); * Partial remission (reduction of tumor markers ≥ 50%); ③No change (decrease of tumor markers <50% or increase ≤25%); ④Disease progression (tumor markers increased> 25%).
Tumor volume assessment: According to RECIST (version 1.1).
Time frame: 20 years
* Complete response: All target lesions disappear, and the short axis of any pathological lymph nodes must be reduced to <10 mm. * Partial Response: The total diameter of the target lesions is reduced by at least 30% compared with the baseline. * Progressive Disease: Take the minimum value of the sum of the diameters of all target lesions measured during the study as the reference, and the relative increase in diameter sum by at least 20% ④Stable Disease: Based on the minimum value of the sum of the diameters of all target lesions measured during the study, the reduction of the target lesion did not reach PR, and the degree of increase did not reach PD, between PR and PD.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
- Individual participant dataSharing planned: Undecided
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.
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 Complicated Adrenal Tumor Diseases, run by Shanghai Jiao Tong University School of Medicine 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Dec 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yiran Jiang, MD (8621-64370045, rainy0409@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor biochemical marker treatment response (time frame: 20 years). The study lists 2 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 27 Dec 2021.