Cervical CancerNCT01262144
SUV Max as Predictor of Outcome in Cervical Cancer
An observational study of Cervical Cancer, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Cervical Cancer is staged clinically, not surgically. Patients in whom an extensive disease is identified are not usually eligible for surgery. PET-CT is used to support staging. However, some patients received surgery after staging and subsequently require radio/chemotherapy due to findings on operation. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to not given
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Females age 18-80, diagnosed with cervical cancer
Who may be able to join
- having stating PET-CT stored on site
- treated with surgery
Who cannot join
- not eligible for surgery based on PET-CT, clinical stage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Value of SUV-Max in PET-FDG in Predicting Outcome of Surgery Vis a Vis Need for Radiotherapy
Cervical Cancer is staged clinically, not surgically. Patients in whom an extensive disease is identified are not usually eligible for surgery. PET-CT is used to support staging. However, some patients received surgery after staging and subsequently require radio/chemotherapy due to findings on operation.
This study will attempt to find a correlation between SUV-Max on PET-CT and subsequent outcomes i.e. need for adjuvant therapy.
- Conditions
- Cervical Cancer
- Being tested
- Radiotherapy
- Keywords
- Cervical Cancer, PET CT, SUV Max
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Radiotherapy for cervical cancer
| Study group | Role | What they receive |
|---|---|---|
| Case group | Not described Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Administration of adjuvant therapy
Measured: immediately following surgery
Secondary outcomes (1)
Overall survival
Measured: surgery - present day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Amnon Amit, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262144
- Sponsor's protocol ID
- 421CTIL
- Status last verified
- Nov 2010
- First submitted
- 23 Nov 2010
- Last updated
- 17 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Value of SUV-Max in PET-FDG in Predicting Outcome of Surgery Vis a Vis Need for Radiotherapy
- ClinicalTrials.gov ID
- NCT01262144
- Acronym / sponsor ID
- 421CTIL
- Conditions
- Cervical Cancer
- Keywords
- Cervical Cancer, PET CT, SUV Max
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Aug 2010
- First posted
- 17 Dec 2010 (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.
Cervical Cancer is staged clinically, not surgically. Patients in whom an extensive disease is identified are not usually eligible for surgery. PET-CT is used to support staging. However, some patients received surgery after staging and subsequently require radio/chemotherapy due to findings on operation.
This study will attempt to find a correlation between SUV-Max on PET-CT and subsequent outcomes i.e. need for adjuvant therapy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Females age 18-80, diagnosed with cervical cancer
Key inclusion criteria (2 listed)
- having stating PET-CT stored on site
- treated with surgery
Key exclusion criteria (1 listed)
- not eligible for surgery based on PET-CT, clinical stage
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 |
|---|---|---|
| RadiotherapyRadiotherapy for cervical cancer | Radiation | Case group |
Primary outcome
Administration of adjuvant therapy
Time frame: immediately following surgery
1 secondary outcome
Overall survival
Time frame: surgery - present day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2010.
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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.
Amnon Amit, MD principal investigator
Rambam Health Care Campus
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 Cervical Cancer, run by Rambam Health Care Campus at 1 site in Israel.
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 1 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: finished, as of the sponsor's last update on 17 Dec 2010. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Administration of adjuvant therapy (time frame: immediately following surgery). 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 17 Dec 2010.