Biomarkers in Patients With Metastatic Breast Cancer
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: identify biomarkers.
- Кому может быть актуально
- Состояния в реестре: Identify the Number of Eligible Patients for Immunotherapy According to the Epidemiological and Biological Profile in Tunisia. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
In order to allow Tunisian patients with breast cancer to access immunotherapies, and innovative treatments to extend life expectancy of patients with breast cancer with a poor prognosis, it is important to study the epidemiological profile of Tunisian cancers breast, in terms of PD-L1 expression, tumor mutational burden (TMB), microsatellite instability status (MSI) and rate of TILs, in metastatic and locally advanced cases, in Tunis, over a one-year follow-up period. It is also important to study other inflammatory and tumor biomarkers which would have a prognostic or even therapeutic value: * serum dosage of LDH (lactate dehydrogenase) * IL-6 (interleukin 6) * CRP (C-reactive protein) * absolute count of lymphocytes (CLA) and eosinophils * quantification of circulating tumor DNA before treatment and under treatment. The primary objective id to identify the epidemiological profile of the biological signature (PD-L1 / TMB / MSI/HRD/ TILs) of patients with locally advanced or metastatic breast carcinoma before and during the systemic treatment.
Подробное описание
Procedure:
1. Verification of the inclusion / non-inclusion criteria 2. Signing the consent form 3. Surgical, Medical and family history, ongoing treatments 4. Clinical Examination1 5. Radiological examinations 2 6. TNM Classification (Appendix 3) 7. Standard biochemical assessment 3 8. Inflammatory assessment (CRP, LDH, IL6) 9. Hematological assessment (NFS, platelets) 10. Tumor markers (ACE, CA15-3) 11. Histological and molecular examination 4:
* Expression PD-L1 by IHC (Immuno-Histochemistry) * TILs by IHC * \- MSI status: MMR \* proteins (Mismatch Repair Protein) (Appendix 4) by NGS via TruSight™ Oncology 500 Kit (Illumina) , if PD-L1\>1% * Score HRD : by NGS via TruSight™ Oncology 500 Kit (Illumina) , if PD-L1\>1% * TMB mutational burden by next generation sequencing "Next Generation Sequencing" (NGS) via TruSight™ Oncology 500 Kit (Illumina) if PD-L1\>1% * tDNA by digital PCR 12. Radiological evaluation5 13. Indication of surgery? (if yes type of surgery to be specified) 14. Evaluation of adverse events / effects: Tolerance of the previous treatment 15. Completion the source documents and the eCRF
Clinical Exam1: * General State according to the WHO classification or according to the Karnowsky Index * Breast examination: inspection (symmetry, appearance of the skin), palpation (size of the tumor, presence of mammary discharge). * Examination of the axillary and supraclavicular lymph node areas * Abdominal examination * Pulmonary auscultation * Skeleton examination Radiological examination2: * Mammography and echo-mammary * Thoraco-abdomino-pelvic CT scan * Bone scintigraphy * Cardiac ultrasound
Standard biochemical balance3:
Blood group, creatininemia, blood ionogram, calcemia, glycemia, bilirubin, transaminases, gamma-GT, alkaline phosphatases, total cholesterol, triglycerides, uric acid, albuminemia.
Histological examination4: * Biopsy with part number assigned by the laboratory, name of the laboratory * Histological type * Grade of Scarff-Bloom and Richardson (SBR) * Estrogen receptors, progesterone receptors * Her2Neu * Ki67 * PD-L1 * TILs * MMR
Molecular Examination4: * MSI status by pentaplex PCR and capillary electrophoresis by NGS platform via the TruSight™ kit Oncology 500 (Illumina) * HRD Score by NGS platform via the TruSight™ kit Oncology 500 (Illumina) * Mutational burden TMB by NGS platform via the TruSight™ kit Oncology 500 (Illumina) * Circulating tumor DNA by digital PCR Radiological assessment5: * If the stage is locally advanced (appendix 3): Breast ultrasound +/- Mammography +/- Breast MRI * If metastatic stage: Thoraco-abdomino-pelvic CT scan 12 \| 27 Visit details
• Initial visit D0 (V1) * Signature of informed consent form * Verification of inclusion / non-inclusion criteria * Medical, surgical and family history * Current treatments * Clinical examination1 * Radiological examinations2 * TNM classification * Standard biochemical assessment3 * Inflammatory assessment (CRP, LDH, IL6) * Hematological assessment (NFS, platelets) * Tumor markers (ACE, CA15-3) * Histological examination with immunohistochemistry and molecular4: * Biopsy with part number assigned by the lab, name of the lab * Histological type * SBR grade * Estrogen receptors, progesterone receptors * Her2Neu * Ki67 * PD-L1 * TILs * MMR * MSI * HRD * TMB mutational charge * ctDNA o Completion of source documents and eCRF
* Visit after 3 chemotherapy treatment cycles (V2)
* Current treatments * Clinical examination1 * Hematological assessment (NFS, platelets) * Tumor markers (ACE, CA15-3) * Radiological assessment5 * Evaluation of adverse events / effects: Tolerance of the previous treatment * Completion of source documents and eCRF * Assessment visit (V3) o Current treatments
o Clinical examination1 * TNM classification * Inflammatory assessment (CRP, LDH, IL6) * Hematological assessment (NFS, platelets) * Tumor markers (ACE, CA15-3) * Histological examination with immunohistochemistry and molecular4: * Biopsy with part number assigned by the lab, name of the lab * Histological type * SBR grade 13 \| 27 * Estrogen receptors, progesterone receptors * Her2Neu * Ki67 * PD-L1 * TILs * ctDNA
o Radiological assessment5
o Assessment of adverse events / effects
o Fill in the source files and the eCRF * Follow-up visit at 3 months (V4)
o Current treatments
o Clinical examination1
o Tumor markers (ACE, CA15-3)
o Radiological examinations2
o Evaluation of adverse events / effects * Completion of source documents and eCRF * Follow-up visit at 6 months (V5) o Current treatments o Clinical examination1 o Tumor markers (ACE, CA15-3)
* Radiological examinations2 * Evaluation of adverse events / effects * Completion of source documents and eCRF
Вмешательства
- Диагностический тест identify biomarkers
Identify the epidemiological profile of the biological signature (PD-L1 / TMB / MSI/HRD/ TILs) of patients with locally advanced or metastatic breast carcinoma
Первичные конечные точки
- number of eligible patients for immunotherapy [Срок оценки: 2023 to 2027]
Вторичные конечные точки (1)
- Relevance of immunotherapy in Tunisia [Срок оценки: 2023 to 2027]
Критерии участия
Критерии включения
- Age ≥ 18 years old.
- Signed informed consent
- Histological evidence of breast carcinoma.
- Locally advanced (stage III inoperable) or metastatic (stage IV) carcinoma, the metastases of which have been diagnosed straight away or after adjuvant or neoadjuvant treatment.
- No treatment for metastatic disease.
- Metastatic disease: histological evidence of metastasis
- Patients who will receive systemic treatment (chemotherapy, targeted therapy, hormone therapy)
- Life expectancy greater than 3 months
Критерии исключения
- Non-epithelial breast cancer
- Non-biopsiable metastases
- Patients who have received before systemic treatment for metastatic disease (chemotherapy, targeted therapy, hormone therapy)
- Patients with a contraindication to chemotherapy, and / or hormone therapy, and
/ or targeted therapy.
- Foreign patients
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT05871788 · ECOCS2020-01