Breast CancerSFPMAMMANCT06429995
Standard Follow-up Program (SFP) for Breast Cancer Patients
An observational study of Breast Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Motive: In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2008to 1 Jan 2030
- How long will I take part?
- 30 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast cancer receiving radiotherapy
Who may be able to join
- Patients with breast cancer Patients receiving a radiotherapy dose
Who cannot join
- Failure to comply with any of the inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Motive:
In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from breast cancer patients.
Read more
Goal:to set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.
A standard database of patiënts receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.
To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.
A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.
- Conditions
- Breast Cancer
- Being tested
- Radiotherapy
- Keywords
- Acute toxicity, Late toxicity, Prediction models
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Also called chemoradiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of Acute toxicity
Acute Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).
Measured: Before start of radiation therapy and during radiation therapy and at 2 weeks after last day of radiation therapy.
Score of Late toxicity
Late Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).
Measured: At one and two years after last day of radiation therapy.
Secondary outcomes (2)
Overall survival
Overall survival
Measured: At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.
Loco-regional tumor control
Loco-regional tumor control
Measured: At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start1 Jan 2008
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- 10,000 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Crijns, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429995
- Sponsor's protocol ID
- SFP MAMMA
- Acronym
- SFPMAMMA
- Status last verified
- May 2024
- First submitted
- 22 Sep 2023
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stanton AL, Krishnan L, Collins CA. Form or function? Part 1. Subjective cosmetic and functional correlates of quality of life in women treated with breast-conserving surgical procedures and radiotherapy. Cancer. 2001 Jun 15;91(12):2273-81.
PubMed 11413515Sneeuw KC, Aaronson NK, Yarnold JR, Broderick M, Regan J, Ross G, Goddard A. Cosmetic and functional outcomes of breast conserving treatment for early stage breast cancer. 1. Comparison of patients' ratings, observers' ratings, and objective assessments. Radiother Oncol. 1992 Nov;25(3):153-9. doi: 10.1016/0167-8140(92)90261-r.
PubMed 1470691
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Follow-up Program (SFP) for Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06429995
- Acronym / sponsor ID
- SFPMAMMA / SFP MAMMA
- Conditions
- Breast Cancer
- Keywords
- Acute toxicity, Late toxicity, Prediction models
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 28 May 2024 (actual)
- 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.
Motive:
In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from breast cancer patients.
Goal:to set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.
A standard database of patiënts receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.
To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.
A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Years
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer receiving radiotherapy
Key inclusion criteria (1 listed)
- Patients with breast cancer Patients receiving a radiotherapy dose
Key exclusion criteria (1 listed)
- Failure to comply with any of the inclusion criteria
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 |
|---|---|---|
| RadiotherapyAlso: chemoradiation | Radiation | – |
Primary outcome
Score of Acute toxicity
Time frame: Before start of radiation therapy and during radiation therapy and at 2 weeks after last day of radiation therapy.
Acute Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).
Score of Late toxicity
Time frame: At one and two years after last day of radiation therapy.
Late Toxicity is measured with Common Terminology Criteria for Adverse Events (CTCAE).
2 secondary outcomes
Overall survival
Time frame: At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.
Loco-regional tumor control
Time frame: At 2 weeks after last day of radiation therapy and thereafter yearly, anticipated average 5-10 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Background: PubMed 11413515Stanton AL, Krishnan L, Collins CA. Form or function? Part 1. Subjective cosmetic and functional correlates of quality of life in women treated with breast-conserving surgical procedures and radiotherapy. Cancer. 2001 Jun 15;91(12):2273-81.
- Background: PubMed 1470691Sneeuw KC, Aaronson NK, Yarnold JR, Broderick M, Regan J, Ross G, Goddard A. Cosmetic and functional outcomes of breast conserving treatment for early stage breast cancer. 1. Comparison of patients' ratings, observers' ratings, and objective assessments. Radiother Oncol. 1992 Nov;25(3):153-9. doi: 10.1016/0167-8140(92)90261-r.
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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.
Anne Crijns, MD, PhD principal investigator
University Medical Center Groningen
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 Breast Cancer, run by University Medical Center Groningen 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 1 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: enrolling by invitation, as of the sponsor's last update on 28 May 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Score of Acute toxicity (time frame: Before start of radiation therapy and during radiation therapy and at 2 weeks after last day of radiation therapy.). The study lists 2 primary outcomes in all. 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 NCT06429995, which also lists 2 linked publications.
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 28 May 2024.