| Registry | NCT03017573, acronym SCANDARE |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, basic science |
| Enrollment | 1050 (Estimated) |
| Sponsor | Institut Curie (Other) |
| Conditions | Ovarian Cancer, Triple-Negative Breast Cancer, Head and Neck Cancer, Cervical Cancer, Sarcoma, Vulva Cancer |
| Interventions | Tumor biopsies / Tumor surgery, Blood withdrawal (Procedure) |
| Dates | start 2017-01-06, primary completion 2029-08-06 (estimated), completion 2032-01-06 (estimated), first posted 2017-01-11, last updated 2026-02-03 |
| Locations | 6 sites in France |
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All trials for Ovarian Cancer All trials for Triple-Negative Breast Cancer All trials of Tumor biopsies / Tumor surgery All trials of Blood withdrawal
SCANDARE is a prospective biobanking study on tumor (+/- nodes), plasma and blood samples at different time points in ovarian, triple negative breast, Head and Neck Cancer, advanced stage treatment-naïve cervical or vulva cancer and sarcoma (breast angiosarcoma and uterine sarcoma) cancers. This study will allowed to identify new molecular and/or immunological biomarkers associated with clinical and biological features of the tumors. All patients will receive standard treatment according to the stage of the diseases and usual procédures.
Patients will have blood and +/- tumor samples at the following times :
1. if eligible for surgery :
* at surgery (blood + tumor and nodes)
* after surgery (blood)
* 6 months after surgery if non recurrence (Blood)
* before cycle 1 of adjuvant chemotherapy or before radiotherapy (blood + tumor biopsie and nodes if possible)
* before cycle 2 of adjuvant chemotherapy or after radiotherapy (blood)
* at progression (blood + tumor biopsie and nodes if possible)
2. if eligible for neoadjuvant chemotherapy :
* before neoadjuvant therapy (blood + tumor biopsie and nodes)
* during neoadjuvant therapy (post cycle 1) (blood)
* at the time of surgery (blood + tumor and nodes)
* 6 months after surgery if non recurrence (Blood)
* before cycle 1 of adjuvant chemotherapy or before radiotherapy (blood + tumor biopsie and nodes)
* before cycle 2 of adjuvant chemotherapy or after radiotherapy (blood)
* at progression (blood + tumor biopsie and nodes)
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Tumor and blood sampling | Experimental | Procedure: Tumor biopsies / Tumor surgery; Procedure: Blood withdrawal | Patients will have a biopsy or a surgery and blood sampling at different time points. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: 1. Tumor types : 1. Newly diagnosed treatment-naïve ovarian cancer patients eligible for surgery or neoadjuvant chemotherapy 2. Newly diagnosed treatment-naïve triple-negative breast cancer patients eligible for surgery or neoadjuvant chemotherapy 3. Newly diagnosed treatment-naïve head and neck cancer patients eligible for surgery 4. Newly diagnosed treatment-naïve vulva cancer (all types) or cervical cancer patients with (1) stage Ia - IIa1 with nodal metastasis, postoperative positive margin or parametrial-vaginal involvement, and (2) stage ≥IIa2). 5. Newly diagnosed treatment-naïve sarcoma cancer patients (1) breast angiosarcoma or (2) uterine sarcoma eligible for surgery or systemic treatment 2. Male or female patients ≥ 18 years of age 3. Signed informed consent Exclusion Criteria: 1. Male or female patients ≤18 years old 2. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 3. Individually deprived of liberty or placed under the authority of a tutor 4. Patients not affiliated to the Social Security System
| Facility | City | Country | Status |
|---|---|---|---|
| Institut Bergonie | Bordeaux | France | Recruiting |
| Centre Oscar Lambret | Lille | France | Recruiting |
| Centre Leon Berard | Lyon | France | Recruiting |
| Institut Curie | Paris | France | Recruiting |
| Institut Curie Hopital Rene Huguenin | Saint-Cloud | France | Recruiting |
| Institut de Cancérologie de Lorraine - Nancy | Vandœuvre-lès-Nancy | France | Not yet recruiting |