Invasive Breast CancerNCT01916837
Genomic Grade Index (GGI): Feasibility in Routine Practice and Impact on Treatment Decisions in Early Breast Cancer
An observational study of Invasive Breast Cancer, run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
In this prospective study the investigators sought to evaluate the feasibility of using the genomic signature - Genomic Grade Index (GGI) - in routine clinical practice and its impact on treatment recommendations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Breast Cancer
- What is being tested?
- Sampling of tumor tissue and Sampling of tumor tissue after breast cancer surgery
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2010to Dec 2010
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study includes patients diagnosed with early-stage invasive breast cancer and operable disease.
Who may be able to join
- Histologically confirmed invasive breast cancer meeting the following criteria:
- T1, T2, or operable T3 disease
- Zero to three positive lymph nodes and no distant metastases
- Operable disease - Must have undergone breast-conserving surgery or mastectomy with either a sentinel node procedure or full axillary clearance
Who cannot join
- No other invasive cancer within the past 5 years except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer
- No psychological, familial, sociological, or geographical condition that would preclude entering into a clinical study
Trial locations and contacts
1 site in 1 country.
About this study
In this prospective study the investigators sought to evaluate the feasibility of using the genomic signature - Genomic Grade Index (GGI) - in routine clinical practice and its impact on treatment recommendations.
Read the detailed description
The primary objective of this study was to evaluate the feasibility of implementing Genomic Grade Index (GGI) in community hospitals in Belgium for breast cancer patients with node negative and 1-3 node positive early breast cancer. GGI would be considered a feasible genomic test if results were obtained in > 70% of evaluated patients.
- Conditions
- Invasive Breast Cancer
- Being tested
- Sampling of tumor tissue, Sampling of tumor tissue after breast cancer surgery
- Keywords
- Breast cancer, Feasibility, Genomic grade index
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling of tumor tissueOther
Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery
Sampling of tumor tissue after breast cancer surgeryOther
Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery
Sampling of tumor tissue after breast cancer surgeryProcedure or surgery
Fresh tumor specimens were sampled prior to adding any fixative and within one hour of surgery
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery. Receives: Other: Sampling of tumor tissue; Other: Sampling of tumor tissue after breast cancer surgery; Procedure: Sampling of tumor tissue after breast cancer surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate in obtaining the Genomic Grade Index in clinical practice
To evaluate the feasibility of implementing Genomic Grade Index in community hospitals in Belgium for breast cancer patients diagnosed with node negative and 1-3 node positive early-stage invasive breast cancer
Measured: 12 months
Secondary outcomes (1)
The impact of Genomic Grade Index results on adjuvant treatment decision
The secondary objective was to evaluate the impact of Genomic Grade Index on adjuvant treatment decisions for patients with early breast cancer. This was done by comparing physicians' treatment recommendations before having knowledge of the GGI test results to recommendations with a hypothetical GG-1 and GG-3 result and to the treatment ultimately administered after discussion with the patient.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive Breast 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
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916837
- Sponsor's protocol ID
- 1668
- Other IDs
- 2009-015521-36, 2009
- Status last verified
- Aug 2013
- First submitted
- 30 Jul 2013
- Last updated
- 6 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Metzger-Filho O, Catteau A, Michiels S, Buyse M, Ignatiadis M, Saini KS, de Azambuja E, Fasolo V, Naji S, Canon JL, Delree P, Coibion M, Cusumano P, Jossa V, Kains JP, Larsimont D, Richard V, Faverly D, Cornez N, Vuylsteke P, Vanderschueren B, Peyro-Saint-Paul H, Piccart M, Sotiriou C. Genomic Grade Index (GGI): feasibility in routine practice and impact on treatment decisions in early breast cancer. PLoS One. 2013 Aug 19;8(8):e66848. doi: 10.1371/journal.pone.0066848. eCollection 2013.
PubMed 23990869
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Grade Index (GGI): Feasibility in Routine Practice and Impact on Treatment Decisions in Early Breast Cancer
- ClinicalTrials.gov ID
- NCT01916837
- Acronym / sponsor ID
- 1668
- Conditions
- Invasive Breast Cancer
- Keywords
- Breast cancer, Feasibility, Genomic grade index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Aug 2013 (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.
In this prospective study the investigators sought to evaluate the feasibility of using the genomic signature - Genomic Grade Index (GGI) - in routine clinical practice and its impact on treatment recommendations.
Detailed description
The primary objective of this study was to evaluate the feasibility of implementing Genomic Grade Index (GGI) in community hospitals in Belgium for breast cancer patients with node negative and 1-3 node positive early breast cancer. GGI would be considered a feasible genomic test if results were obtained in > 70% of evaluated patients.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | – | Other: Sampling of tumor tissue, Other: Sampling of tumor tissue after breast cancer surgery, Procedure: Sampling of tumor tissue after breast cancer surgeryFresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes patients diagnosed with early-stage invasive breast cancer and operable disease.
Key inclusion criteria (4 listed)
- T1, T2, or operable T3 disease
- Zero to three positive lymph nodes and no distant metastases
- Operable disease - Must have undergone breast-conserving surgery or mastectomy with either a sentinel node procedure or full axillary clearance
Key exclusion criteria (2 listed)
- No other invasive cancer within the past 5 years except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer
- No psychological, familial, sociological, or geographical condition that would preclude entering into a clinical study
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 |
|---|---|---|
| Sampling of tumor tissueFresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery | Other | Single arm |
| Sampling of tumor tissue after breast cancer surgeryFresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery | Other | Single arm |
| Sampling of tumor tissue after breast cancer surgeryFresh tumor specimens were sampled prior to adding any fixative and within one hour of surgery | Procedure or surgery | Single arm |
Primary outcome
The success rate in obtaining the Genomic Grade Index in clinical practice
Time frame: 12 months
To evaluate the feasibility of implementing Genomic Grade Index in community hospitals in Belgium for breast cancer patients diagnosed with node negative and 1-3 node positive early-stage invasive breast cancer
1 secondary outcome
The impact of Genomic Grade Index results on adjuvant treatment decision
Time frame: 12 months
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 6 Aug 2013.
- Derived from this study: PubMed 23990869Metzger-Filho O, Catteau A, Michiels S, Buyse M, Ignatiadis M, Saini KS, de Azambuja E, Fasolo V, Naji S, Canon JL, Delree P, Coibion M, Cusumano P, Jossa V, Kains JP, Larsimont D, Richard V, Faverly D, Cornez N, Vuylsteke P, Vanderschueren B, Peyro-Saint-Paul H, Piccart M, Sotiriou C. Genomic Grade Index (GGI): feasibility in routine practice and impact on treatment decisions in early breast cancer. PLoS One. 2013 Aug 19;8(8):e66848. doi: 10.1371/journal.pone.0066848. eCollection 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Invasive Breast Cancer, run by Jules Bordet Institute at 1 site in Belgium.
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 4 inclusion and 2 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 6 Aug 2013. 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 Belgium. 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?
The success rate in obtaining the Genomic Grade Index in clinical practice (time frame: 12 months). 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 NCT01916837, which also lists 1 linked publication.
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 6 Aug 2013; AzTrials last refreshed its copy on 6 Nov 2026.