Condition category
Cancer
Date applied
09/05/2020
Date assigned
12/05/2020
Last edited
12/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Most cancers use more glucose (a type of sugar) than normal cells. FDG is a molecule that is taken up by cancer cells in the same way as glucose and can be visualised in a PET scan to show where there are tumours in the body. This technique is widely used to investigate whether breast cancer has spread to other areas of the body, but it is not clear whether it would also be useful in the early stages of breast cancer, when the cancer can still be treated with surgery alone.
This study will use medical records of patients diagnosed with breast cancer at a Brussels hospital in the years from 2002 to 2015. It will look at the FDG-PET imaging the patients received and how long they survived without cancer and in total to see if there are any patterns.

Who can participate?
There is no active participation in this study. Medical records of people treated 2002-2015 will be analysed.

What does the study involve?
The researchers will take information from medical records and FDG-PET scans. This information will be analysed to see if there are any links between certain FDG-PET results and whether patients were more or less likely to die from their breast cancer.

What are the possible benefits and risks of participating?
There are no potential risks or benefits to participants.

Where is the study run from?
Brussels University Hospital (Belgium)

When is the study starting and how long is it expected to run for?
July 2015 to January 2020

Who is funding the study?
The investigator is funding the costs of the study.

Who is the main contact?
Dr Vincent Vinh-Hung, vh@onco.be

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vincent Vinh-Hung

ORCID ID

http://orcid.org/0000-0002-6403-6120

Contact details

Avenue Victor Lamon
Ramville 4 apt 62
Fort-de-France
97200
Martinique
+33 652411567
vh@onco.be

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1.03

Study information

Scientific title

Prognostic value of pre-treatment 18FDG-PET in operable breast cancer

Acronym

PET2015UZ

Study hypothesis

18FDG-PET is a significant predictor of outcome in breast cancer.

Ethics approval

Approved 21/10/2015, Commissie Medische Ethiek (O.G. 016) Universitair Ziekenhuis Brussel [Brussels University Hospital Medical Ethics Committee] (Reflectiegroep Biomedische Ethiek, Laarbeeklaan 101, 1090 Brussels, Belgium; +32 2 477 55 84; commissie.ethiek@uzbrussel.be), ref: B.U.N. 143201525542

Study design

Single-centre retrospective observational study with longitudinal cohorts 2002-2008 and 2009-2015

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

No participant information sheet available

Condition

Operable breast cancer.

Intervention

Records of patients with breast cancer who received pre-operative 18FDG-PET scans will be included. The records will be anonymised and the following types of data extracted:
1. Clinical-pathological characteristics, including age at diagnosis, histological tumor type, pathological grade etc
2. FDG-PET characteristics, including PET positivity and standard uptake value (SUV) etc
3. Outcomes, including local and regional recurrence, disease status at last follow-up, cause of death etc
4. Dates, including date of histological diagnosis, date of recurrence etc

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

1. Overall survival up to 13 years after diagnosis assessed using patient medical records
2. Disease-free survival up to 13 years after diagnosis assessed using patient medical records

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

22/07/2015

Overall trial end date

31/01/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients treated at the UZ Brussel
2. Diagnosed in the period 2002-2015
3. Primary breast cancer
4. Histologically confirmed
5. Operable
6. Pre-treatment FDG-PET or PET/CT

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

182

Participant exclusion criteria

1. Previous history of cancer
2. Primary sarcoma of the breast
3. Palliative surgery for symptom control
4. No histopathological confirmation of cancer
5. Noninvasive carcinoma
6. Metastatic disease demonstrated by imaging modes other than FDG-PET

Recruitment start date

01/01/2002

Recruitment end date

31/12/2015

Locations

Countries of recruitment

Belgium

Trial participating centre

Oncologisch Centrum, UZ Brussel
101 Laarbeeklaan
Jette
1090
Belgium

Sponsor information

Organisation

Universitair Ziekenhuis Brussel

Sponsor details

Laarbeeklaan 101
Brussel
1090
Belgium
+32 24776144
mark.deridder@uzbrussel.be

Sponsor type

Hospital/treatment centre

Website

https://www.uzbrussel.be/en/web/oncologisch-centrum

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

End analyses and publication expected from June to December 2020.

IPD sharing statement:
The datasets generated at the analysis of the study will be made available upon request from the main contact, Vincent Vinh-Hung (vh@onco.be or anhxang@gmail.com), who will inform the UZ Brussel Ethics Committee.

Intention to publish date

30/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/05/2020: Uploaded protocol Version 1.03 22 July 2015 (not peer reviewed). 12/05/2020: Trial's existence confirmed by Brussels University Hospital Medical Ethics Committee.