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Prospektiv utvärdering av enbart bröstbevarande kirurgi vid lågrisk ductal carcinoma in situ (DCIS) (ELISA)

1 oktober 2026 uppdaterad av: Ontario Clinical Oncology Group (OCOG)

Prospektiv utvärdering av enbart bröstbevarande kirurgi vid lågrisk duktalt karcinom in situ definierat av en molekylär expressionsanalys kombinerad med klinisk-patologiska egenskaper

To evaluate whether the combination of clinicopathological factors and the use of the Oncotype DX DCIS score can avoid radiation in women with low risk DCIS who have had breast conserving surgery (BCS)

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

DCIS

Detaljerad beskrivning

A prospective cohort study, conducted in Canada, to prospectively evaluate whether the combination of clinicopathological criteria and the Oncotype DX DCIS score can identify a group of women at very low risk of local recurrence following breast conserving surgery who do not require breast radiation therapy. We plan to screen 809 consenting women who will have their tumour tissue specimen sent to Exact Sciences to assess their DCIS score. We anticipate that 526 women will have an Oncotype DX DCIS score with a predicted 10-year risk of local recurrence ≤10%, these women will be enrolled and followed as part of the study.

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. A two-step registration/enrollment process will be implemented.

Data related to the patient demographics, surgery details, tumour characteristics and ECOG performance will be collected. The patient's tumour specimen will be sent for analysis to Exact Sciences. The DCIS score results will be sent to the referring physician. OCOG will also receive the DCIS score results. Patients will be followed yearly up to 10 years. Bilateral mammograms and breast exams will be performed annually. The study data will be verified by source documentation.

Studietyp

Observationell

Inskrivning (Beräknad)

526

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Kanada
- Alberta
  - Calgary, Alberta, Kanada, T2N 5G2
    - Arthur J.E. Child Comprehensive Cancer Centre
  - Edmonton, Alberta, Kanada, T6G 1Z2
    - Cross Cancer Institute
- British Columbia
  - Abbotsford British Columbia, British Columbia, Kanada, V2S 0C2
    - BC Cancer - Abbotsford Centre
  - Prince George, British Columbia, Kanada, V2M 7E9
    - BC Cancer - Centre for the North (Prince George)
  - Surrey, British Columbia, Kanada, V3V 1Z2
    - BC Cancer - Fraser Valley Centre
  - Vancouver, British Columbia, Kanada, V5Z 4E6
    - BC Cancer - Vancouver Centre
  - Victoria, British Columbia, Kanada, V8R 6V5
    - BC Cancer - Victoria
- Manitoba
  - Winnipeg, Manitoba, Kanada, R3E 0V9
    - CancerCare Manitoba
- Nova Scotia
  - Halifax, Nova Scotia, Kanada, B3H 1V7
    - QE II HSC - Nova Scotia Cancer Centre
  - Sydney, Nova Scotia, Kanada, B1P 1P3
    - Cape Breton Cancer Centre
- Ontario
  - Barrie, Ontario, Kanada, L4M 6M2
    - Royal Victoria Regional Health Centre
  - Hamilton, Ontario, Kanada, L8V 5C2
    - Juravinski Cancer Centre
  - London, Ontario, Kanada, N6A 4L6
    - London Regional Cancer Program
  - Thunder Bay, Ontario, Kanada, P7B 6V4
    - Regional Cancer Care, Thunder Bay Regional Health Sciences Centre
  - Toronto, Ontario, Kanada, M4N 3M5
    - Sunnybrook Health Science Centre -Odette Cancer Centre
  - Toronto, Ontario, Kanada, M5G 2M9
    - University Health Network - Princess Margaret Cancer Centre
  - Windsor, Ontario, Kanada, N8W 2X3
    - Windsor Regional Cancer Centre
- Quebec
  - Greenfield Park, Quebec, Kanada, J4V 2H1
    - Hôpital Charles Le Moyne (CISSS de la Montérégie-Centre)
  - Montreal, Quebec, Kanada, H4A 3J1
    - McGill University Health Centre
  - Montreal, Quebec, Kanada, H2L 4M1
    - CHUM - Centre Hospitalier de L'Université de Montréal
  - Québec, Quebec, Kanada, G1J 1Z4
    - Centre intégré de cancérologie du CHU de Québec - Université Laval
  - Trois-Rivières, Quebec, Kanada, G8Z 3R9
    - Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie- Centre-du-Québec (CIUSSS MCQ) - Trois-Rivières
- Saskatchewan
  - Regina, Saskatchewan, Kanada, S4T 7T1
    - Allan Blair Cancer Centre
  - Saskatoon, Saskatchewan, Kanada, S7N4H4
    - Saskatoon Cancer Centre

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

46 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Testmetod

Sannolikhetsprov

Studera befolkning

Prospective cohort study conducted in Canada in women with a low 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

Beskrivning

Inclusion Criteria:

Female patient > 45 years of age with DCIS without microinvasion.
Tumour size ≤ 2.5cm.
Treated by BCS with clear resection margins ≥ 2 mm or no residual disease on re-excision.*

* Patients with anterior margins and posterior margins ≥1 mm are eligible. Or if the dissection was confirmed to be taken to skin and down to fascia with no DCIS present at inked margins.
Oncotype DX DCIS score with a predicted 10-year risk of LR ≤10%.

Exclusion Criteria:

Multifocal DCIS.
History of any invasive breast cancer or non-invasive breast cancer in the ipsilateral breast.
Synchronous or previous invasive or non-invasive breast cancer.
Prior history of invasive cancer within the last 5 years, excluding non-melanoma skin cancers.
ECOG performance status ≥3.
Life expectancy <10 years.
Geographic inaccessibility for follow-up.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Observationsmodeller: COHORT
Tidsperspektiv: PROSPECTIVE

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
Single Arm Cohort Evaluating the risk of Local Recurrence (LR) in a group of women postulated to be at low risk of LR following Breast Conserving Surgery alone defined by a combination of clinicopathological factors and Oncotype DX DCIS score.

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Ipsilateral local recurrence (LR) Tidsram: 5 Year	Defined as recurrent invasive or in situ cancer in the ipsilateral breast	5 Year

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Ipsilateral invasive local recurrence Tidsram: 5 Year	defined as time from study registration to time of recurrent invasive cancer in the ipsilateral breast	5 Year
Breast cancer recurrence-free interval (RFI) Tidsram: 5 Year	defined as time from study registration to time of documented recurrent disease (ipsilateral breast (DCIS or invasive), regional, distant or death from breast cancer	5 Year
Distant disease-free survival (DDFS) Tidsram: 5 Year	defined as time from study registration to distant recurrence	5 Year
Disease-free survival (DFS) Tidsram: 5 Year	defined as time from registration to time of LR (DCIS or invasive), regional and distant recurrence, contralateral breast cancer, new primary (non-breast) and death from any cause	5 Year
Overall survival (OS) Tidsram: 5 Year	defined as time from registration to death of any cause	5 Year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Ontario Clinical Oncology Group (OCOG)

Samarbetspartners

Canadian Institutes of Health Research (CIHR)

Hamilton Health Sciences Corporation

Utredare

Huvudutredare: Eileen Rakovitch, M.D., Sunnybrook Research Institute, Sunnybrook Health Science
Huvudutredare: Tim Whelan, M.D, Juravinski Cancer Centre

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

<p>TRACE/OCOG website accessed by clinical centres</p>

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

23 november 2022

Primärt slutförande (Beräknad)

30 november 2030

Avslutad studie (Beräknad)

30 november 2035

Studieregistreringsdatum

Först inskickad

10 mars 2021

Först inskickad som uppfyllde QC-kriterierna