DCISDUCHESSNCT02766881
Evaluation of the DCIS Score for Decisions on Radiotherapy in Patients With Low/Intermediate Risk DCIS
An observational study of DCIS, run by Ontario Clinical Oncology Group (OCOG) at 12 sites in Canada.
Trial summary
To evaluate whether the use of the Oncotype DX DCIS score can guide delivery of radiation in women with low to moderate risk DCIS who have had breast conserving surgery Read more about this study
- Who is it for?
- Ages 46 years and older, women only
- Conditions the study is for
- DCIS
- How many people
- 281 participants
- Where
- 12 sitesCanada
- Study dates
- Aug 2016to 30 Sep 2019
- 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 46 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Prospective cohort study conducted in Ontario in women with a low to moderate risk DCIS following breast conserving surgery who are candidates for radiation. Eligibility status should be confirmed by the referring physician or delegate prior to enrollment. It is important that no exceptions are made to the eligibility criteria. Questions related to eligibility requirements and/or specific criteria should be addressed with OCOG prior to enrollment
Who may be able to join
- Women with newly diagnosed breast cancer treated by definitive surgery with histological evidence limited to DCIS.
Who cannot join
- Age < or = 45;
- Treated by mastectomy;
- Surgical margins of <1mm;(re-excisions may be performed where results are regarded as clear margins, these cases will not exclude patients);
- Tumour size >2.5cm;
- Any invasive breast cancer including micro invasion;
- Histological evidence of multifocality (defined as having more than one distinct focus of DCIS with >5mm of intervening benign breast tissue in one quadrant of the breast);
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- Any associated lobular carcinoma in situ;
- Previous diagnosis of ipsilateral invasive carcinoma or DCIS of the breast;
- Any contraindication for whole breast irradiation such as chronic heart or lung disease or previous ipsilateral chest wall radiotherapy;
- Physician/patient unwilling to comply with study protocol; and
- Inability to provide informed consent (e.g. dementia or severe cognitive impairment).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Canada12 sites
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G1Z2
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, K7L 5P9
London Regional Cancer Centre
London, Ontario, N6A4L6
Credit Valley Hospital
Mississauga, Ontario, L5M2N1
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 8L6
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
BC Cancer Agency - Vancouver Island
Victoria, British Columbia, V8R6V5
About this study
Official title: Evaluation of the Ductal Carcinoma In Situ Score for Decisions on Radiotherapy in Patients With Low/Intermediate Risk DCIS
To evaluate whether the use of the Oncotype DX DCIS score can guide delivery of radiation in women with low to moderate risk DCIS who have had breast conserving surgery
Read the detailed description
A prospective cohort study, conducted in Canada, to evaluate whether the use of the DCIS score changes the treatment recommended and the treatment received in women with low to moderate risk DCIS following breast conserving surgery who are candidates for radiation therapy. We plan to study 280 eligible, consenting women who will have their tumour tissue specimen sent to Genomic Health to assess their DCIS score.
At each centre, all patients with DCIS referred to radiation oncology will be documented. When a physician identifies an eligible patient, the patient will be approached by the referring physician or delegate to voluntarily provide informed consent to participate in this study. Consenting patients will be registered through the Ontario Clinical Oncology Group's (OCOG) web-based registration system. Data related to the patient demographics, surgery details, and tumour characteristics will be collected. The preliminary treatment recommendation and patient preference for treatment will be documented. Patient Decisional Conflict will be documented by the patient using the Decisional Conflict Scale (DCS). The patient's tumour specimen will be sent for analysis to Genomic Health. DCIS score results will be sent to the referring physician. OCOG will also receive the DCIS score results. The final treatment recommendation, patient preference, and treatment received by the patient will be documented. Patient decisional conflict will be documented by the patient using the DCS. The study data will be verified by source documentation.
- Conditions
- DCIS
- Keywords
- Ductal Carcinoma in Situ, DSC, Breast Conserving Surgery
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with DCIS | Whether patients with DCIS receive radiotherapy based on Oncotype DX DCIS score, radiation oncologist treatment recommendation and patient's decision. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in radiotherapy treatment recommendation made by physician
The primary outcome is change in treatment recommendation by the radiation oncologist. Physicians will be asked to indicate their preliminary treatment recommendation at the first visit based on clinical factors alone. They will be asked to describe course of radiation including dose and number of fractions. They will then be asked to make a final treatment recommendation when the DCIS score is available. If the physician final recommendation is not consistent with the DCIS score predicted treatment, they will be asked to indicate reasons for their recommendation. If radiation is recommended, they will be asked to indicate the treatment prescription including dose and number of fractions. The actual treatment received by the patient will also be collected.
Measured: 2.5 years
Secondary outcomes (1)
Change in radiotherapy treatment preference by patient
Secondary outcomes will include change in treatment preference by the patient for radiotherapy and change in recommendations by the physician for hormonal therapy or further surgery. It will also compare physician's prediction of LR with or without radiation that is estimated by the DCIS score. Finally, change in level of patient decisional conflict as measured by DCS will also be collected. The DCS was developed and used to evaluate the effect of decision aids on decision making by health consumers.The assumption was that decision aids would reduce the uncertainty and confusion in choosing a course of action. Decisional conflict is a state of uncertainty about the course of action to take.
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startAug 2016
- Primary completion13 Jun 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DCISStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eileen Rakovitch, M.D., Principal investigator, Sunnybrook Health Sciences Odette Cancer CentreTim Whelan, M.D., Principal investigator, Juravinski Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766881
- Sponsor's protocol ID
- OCOG-2016-DUCHESS
- Acronym
- DUCHESS
- Status last verified
- Aug 2019
- First submitted
- 6 May 2016
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Genomic Health will provide results to referring physician, OCOG will have access to results
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ductal Carcinoma In Situ Score for Decisions on Radiotherapy in Patients With Low/Intermediate Risk DCIS
- ClinicalTrials.gov ID
- NCT02766881
- Acronym / sponsor ID
- DUCHESS / OCOG-2016-DUCHESS
- Conditions
- DCIS
- Keywords
- Ductal Carcinoma in Situ, DSC, Breast Conserving Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 13 Jun 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 10 May 2016 (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.
To evaluate whether the use of the Oncotype DX DCIS score can guide delivery of radiation in women with low to moderate risk DCIS who have had breast conserving surgery
Detailed description
A prospective cohort study, conducted in Canada, to evaluate whether the use of the DCIS score changes the treatment recommended and the treatment received in women with low to moderate risk DCIS following breast conserving surgery who are candidates for radiation therapy. We plan to study 280 eligible, consenting women who will have their tumour tissue specimen sent to Genomic Health to assess their DCIS score.
At each centre, all patients with DCIS referred to radiation oncology will be documented. When a physician identifies an eligible patient, the patient will be approached by the referring physician or delegate to voluntarily provide informed consent to participate in this study. Consenting patients will be registered through the Ontario Clinical Oncology Group's (OCOG) web-based registration system. Data related to the patient demographics, surgery details, and tumour characteristics will be collected. The preliminary treatment recommendation and patient preference for treatment will be documented. Patient Decisional Conflict will be documented by the patient using the Decisional Conflict Scale (DCS). The patient's tumour specimen will be sent for analysis to Genomic Health. DCIS score results will be sent to the referring physician. OCOG will also receive the DCIS score results. The final treatment recommendation, patient preference, and treatment received by the patient will be documented. Patient decisional conflict will be documented by the patient using the DCS. The study data will be verified by source documentation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with DCIS | – | –Whether patients with DCIS receive radiotherapy based on Oncotype DX DCIS score, radiation oncologist treatment recommendation and patient's decision. |
Who may qualify
- Ages
- 46 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective cohort study conducted in Ontario in women with a low to moderate risk DCIS following breast conserving surgery who are candidates for radiation. Eligibility status should be confirmed by the referring physician or delegate prior to enrollment. It is important that no exceptions are made to the eligibility criteria. Questions related to eligibility requirements and/or specific criteria should be addressed with OCOG prior to enrollment
Key inclusion criteria (1 listed)
- Women with newly diagnosed breast cancer treated by definitive surgery with histological evidence limited to DCIS.
Key exclusion criteria (11 listed)
- Age < or = 45;
- Treated by mastectomy;
- Surgical margins of <1mm;(re-excisions may be performed where results are regarded as clear margins, these cases will not exclude patients);
- Tumour size >2.5cm;
- Any invasive breast cancer including micro invasion;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in radiotherapy treatment recommendation made by physician
Time frame: 2.5 years
The primary outcome is change in treatment recommendation by the radiation oncologist. Physicians will be asked to indicate their preliminary treatment recommendation at the first visit based on clinical factors alone. They will be asked to describe course of radiation including dose and number of fractions. They will then be asked to make a final treatment recommendation when the DCIS score is available. If the physician final recommendation is not consistent with the DCIS score predicted treatment, they will be asked to indicate reasons for their recommendation. If radiation is recommended, they will be asked to indicate the treatment prescription including dose and number of fractions. The actual treatment received by the patient will also be collected.
1 secondary outcome
Change in radiotherapy treatment preference by patient
Time frame: 2.5 years
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 19 Feb 2020.
- OCOG website accessed by clinical centresLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Genomic Health will provide results to referring physician, OCOG will have access to results
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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.
Eileen Rakovitch, M.D. principal investigator
Sunnybrook Health Sciences Odette Cancer Centre
Tim Whelan, M.D. principal investigator
Juravinski Cancer Centre
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DCIS, run by Ontario Clinical Oncology Group (OCOG) at 12 sites in Canada.
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 11 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 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada. 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 in radiotherapy treatment recommendation made by physician (time frame: 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2020.