AcromegalyNCT01368133
The Observational Study of Growth Hormone-secreting Pituitary Tumors
An observational study of Acromegaly and Pituitary Tumor, run by Huashan Hospital at 1 site in China.
Trial summary
The major purpose of this study is to evaluate the changes of multiple organs in patients with growth hormone-secreting pituitary tumors before and after surgery. Plasma, DNA samples and pituitary tumor tissues will be kept for further analysis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Acromegaly, Pituitary Tumor
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- May 2011to Dec 2013
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The acromegaly patients at Huashan Hospital will be recruited anf followed up prior to surgery and one month, 3 months, 6 months and 12 months after surgery.
Who may be able to join
- Clinical diagnosis of acromegaly
- > 18 years old
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, 200040
Cuiyun Wu, 86-21-52888047, hskyc@fudan.edu.cn
Zhaoyun Zhang, 86-21-52888286, zhaoyunzhang@fudan.edu.cn
About this study
Official title: The Observational Study of the Structures and Functions of Multiple Organs in Patients With Growth Hormone-secreting Tumors
The major purpose of this study is to evaluate the changes of multiple organs in patients with growth hormone-secreting pituitary tumors before and after surgery. Plasma, DNA samples and pituitary tumor tissues will be kept for further analysis.
Read the detailed description
Multiple organs or systems will be affected by excessive growth hormones in patients with acromegaly. The major purpose of this study is to evaluate the changes before and after the pituitary surgery.
- Conditions
- Acromegaly, Pituitary Tumor
- Keywords
- acromegaly, pituitary tumor
- Medical subject headings
- Acromegaly, Pituitary Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by Huashan 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Zhaoyun Zhang, Huashan Hospital
- Investigators
- Yao Zhao, M.D., Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368133
- Sponsor's protocol ID
- 2010M-010
- Status last verified
- Sep 2013
- First submitted
- 6 Jun 2011
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Observational Study of the Structures and Functions of Multiple Organs in Patients With Growth Hormone-secreting Tumors
- ClinicalTrials.gov ID
- NCT01368133
- Acronym / sponsor ID
- 2010M-010
- Conditions
- Acromegaly, Pituitary Tumor
- Keywords
- acromegaly, pituitary tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- May 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 7 Jun 2011 (estimated)
- 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 major purpose of this study is to evaluate the changes of multiple organs in patients with growth hormone-secreting pituitary tumors before and after surgery. Plasma, DNA samples and pituitary tumor tissues will be kept for further analysis.
Detailed description
Multiple organs or systems will be affected by excessive growth hormones in patients with acromegaly. The major purpose of this study is to evaluate the changes before and after the pituitary surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The acromegaly patients at Huashan Hospital will be recruited anf followed up prior to surgery and one month, 3 months, 6 months and 12 months after surgery.
Key inclusion criteria (2 listed)
- Clinical diagnosis of acromegaly
- > 18 years old
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2013.
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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.
Yao Zhao, M.D. principal investigator
Huashan Hospital
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 Acromegaly and Pituitary Tumor, run by Huashan 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 2 inclusion and 0 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 26 Sep 2013. 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?
Contact Jiahui Qiu, M.D. (86-13585951850, qiuhuijiaatsjtu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 26 Sep 2013.