Analysing data from patient medical records to investigate whether a 18FDG-PET scan can predict survival in patients with breast cancer that can be treated with surgery
| ISRCTN | ISRCTN17962845 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17962845 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 1.03 |
| Sponsor | Universitair Ziekenhuis Brussel |
| Funder | Investigator initiated and funded |
- Submission date
- 09/05/2020
- Registration date
- 12/05/2020
- Last edited
- 14/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
Avenue Victor Lamon
Ramville 4 apt 62
Fort-de-France
97200
Martinique
 ORCID ID |
0000-0002-6403-6120 |
|---|---|
| Phone | +33 652411567 |
| vh@onco.be |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre retrospective observational study with longitudinal cohorts 2002-2008 and 2009-2015 |
| Secondary study design | Longitudinal study |
| Study type | Participant information sheet |
| Scientific title | Prognostic value of pre-treatment 18FDG-PET in operable breast cancer |
| Study acronym | PET2015UZ |
| Study objectives | 18FDG-PET is a significant predictor of outcome in breast cancer. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Overall survival up to 13 years after diagnosis assessed using patient medical records |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 31/01/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 182 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Jette
1090
Belgium
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 24/04/2022 | 14/06/2023 | Yes | No | |
| Results article | 10/03/2021 | 14/06/2023 | Yes | No | |
| Dataset | 25/10/2021 | 14/06/2023 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version v1.03 | 22/07/2015 | 12/05/2020 | No | No |
Additional files
- ISRCTN17962845_Protocol_v1.03_22Jul2015.pdf
- Uploaded 12/05/2020
Editorial Notes
14/06/2023: Publication references and dataset added.
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.
