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AzTrials

Cervix CancerNCT01764217

Prediction of Clinical Response and Outcome in Uterine Cervix Cancer

An observational study of Cervix Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Observational study based on the routine clinical treatment and diagnostic course, to correlate imaging features with outcome objectives. Outcome will evaluated as clinical response to the standard treatment and as recurrence and survival in the follow up. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervix Cancer
How many people
100 participants
Where
1 siteNetherlands
Study dates
Jul 2006to Jan 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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Histologically proven cervical uterine cancer, undergoing to conventional radiotherapy.

Who may be able to join

  • Histologically confirmed cervix carcinoma (all subtypes)
  • Tumor Stages FIGO IB - IVA
  • Scheduled for primary curative radiotherapy (either or not combined with chemotherapy or hyperthermia)
  • pre treatment FDG PETCT
  • The patient is willing and capable to comply with study procedures
  • 18 years or older
  • Written informed consent to the treatment

Who cannot join

  • Recent (< 3 months) myocardial infarction
  • Uncontrolled infectious disease
  • Pregnant or breast feeding and/or not willing to take adequate contraceptive measures during the study
  • Previous surgery to the Cervix
  • Previous radiation to the Cervix

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Philippe Lambin

    Maastricht, Limburg, 6202NA

Other trials in Netherlands

About this study

Official title: Predicting Clinical Response and Outcome After Definitive Irradiation With MRI-Guided Adaptive Brachytherapy in Uterine Cervix Cancer

Observational study based on the routine clinical treatment and diagnostic course, to correlate imaging features with outcome objectives. Outcome will evaluated as clinical response to the standard treatment and as recurrence and survival in the follow up. The study hypothesis is that data extracted form FDG-PETCT used in the routine clinical practice can predict outcomes following standard treatment.

Read the detailed description

This study will prospectively collect patients undergoing to the standard diagnostic and treatment protocol in Maastro Clinic. Any difference in the normal procedure will be adopted. The aim is to extrapolate form the PET images some features of the metabolic tumor activity to associate with different outcomes and tumor behaviours.

Conditions
Cervix Cancer
Keywords
Cervix Cancer, SUV, Radiotherapy, Outcome Prediction, Imaging, PET
Medical subject headings
Uterine Cervical Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of SUV-related tumor characteristics predicting recurrence

    • Standard Uptake Value Max (SUV- defined as the ratio of tissue radioactivity concentration (e.g. in MBq/kg=kBq/g) at time t, c(t), and the injected activity ( in MBq) at the time of injection (t=0) divided by the body weight in kg),
    • Metabolic Volume (MV) calculated in cc:volume of the evaluable metabolic activity on the PET scan calculated in a specific Region of Interest (ROI) semiautomatically delineated on the primary tumor in the uterine Cervix

    Measured: Changes of parameters will be calculated on the pretreatment scan, than in average 2.5 months after the last radiotherapy session, than at least each 6 month for the first 2 years, eventually shortening the interval if clinically needed

Secondary outcomes (3)

  1. Change of SUV-related tumor characteristics predicting clinical overall response

    • Standard Uptake Value Max (SUV- defined as the ratio of tissue radioactivity concentration (e.g. in MBq/kg=kBq/g) at time t, c(t), and the injected activity ( in MBq) at the time of injection (t=0) divided by the body weight in kg),
    • Ratio of Pre/Post treatment SUV MAX,

    Measured: Changes of parameters will be calculated on the pretreatment scan, and in average 2.5 months after the last radiotherapy session.

  2. Radiomics Features

    • We will apply a high throughput approach to convert medical images to minable data, where it is hypothesized that it will improve tumor characterization and treatment outcome prediction.
    • Extracted imaging features consist firstly of global properties, providing information on the first order histogram of voxel intensity values within the tumor VOI.
    • Local and regional textural features describing patterns and spatial distribution of voxel intensities, are calculated from respectively gray level co-occurrence and gray level run-length matrix representations. Images will be discretized before texture analysis, which allows for a direct comparison of all calculated textural features between patients. Co-occurrence and gray level run-length matrices are determined considering 26-connected voxels (i.e. voxels were considered to be neighbors in all 13 directions in three dimensions) and a distance of 1 between consecutive voxels. Features derived from the co-occurrence and gray

    Measured: Radiomics features will be evaluated on the preteratment CT-fdg PET scan in average at least 2 weeks after the end of the accrual.

  3. Interobserver variability of Gross Tumor Volume (GTV) contours

    • GTV volume in cc contoured by 5 different observers on pretreatment scan: the difference in cc between each contour obtained will be scored
    • GTV Overlapping fraction rate: the overlapping rate of GTV volume between contours

    Measured: GTV's will be delineated 2 weeks after the end of accrual

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2013 (estimated)
  2. Study startJul 2006
  3. Primary completionJul 2006
  4. Study completionJan 2013

Resources

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 (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01764217
Sponsor's protocol ID
CERVMA01
Status last verified
Mar 2016
First submitted
12 Nov 2012
Last updated
30 Mar 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cervix Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.

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 7 inclusion and 5 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 30 Mar 2016. 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 Netherlands. 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?

Change of SUV-related tumor characteristics predicting recurrence (time frame: Changes of parameters will be calculated on the pretreatment scan, than in average 2.5 months after the last radiotherapy session, than at least each 6 month for the first 2 years, eventually shortening the interval if clinically needed). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01764217.

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 30 Mar 2016.

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