Ignite Creation Date:
2024-07-17 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468124
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-04
Brief Title:
Sensitivity of Organoids to Predict Treatment Outcome in Breast Cancer Metastases
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
Prospective Study to Correlate the Treatment Sensitivity of Patient-derived Organoids With Clinical Outcomes in Breast Cancer Patients With Brain andor Extra-cranial Metastases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PDO
Brief Summary:
The aim of the study is to generate patient-derived organoids PDOs from brain resection or biopsied extra-cranial metastases The preliminary data collected will be used to assess the ability of PDOs to predict patients treatment response and their radio-sensitivity and chemo-sensitivity can be correlated with their survival outcome
Detailed Description:
The SOTO-BC trail is an observation study and the patients will continue their clinical visits and follow-up as per normal standard of care
Patient cohorts
1 Breast cancer patients with brain metastases undergoing surgical resection with or without further radiotherapy SRS or whole brain radiotherapy
2 Breast cancer patients with extra-cranial metastases undergoing surgical resection or biopsy
Primary objective
To assess the percentage of successful generated organoids from resected brain or resectedbiopsied extra-cranial metastases of breast cancer patients
Secondary objectives
1 To assess the sensitivity of radiotherapy in PDOs
2 To assess the sensitivity of the same systemic treatments that the patients previously had and will have in PDOs
3 To correlate the treatment sensitivities of PDOs above with the treatment outcome of patients
4 To correlate IC50 dosesdose response curves above with the objective response rates of patients undergoing same systemic treatment
Study Procedures
Breast cancer patients with resectable brain or extra-cranial metastases or who will undergo a biopsy of the extra-cranial metastases will be asked to consent for this study and for their resectedbiopsied samples to be used to generate PDOs The investigators aim to recruit 20 patients in the pilot phase of the study
When the PDOs contain sufficient cells these cells will be treated with increasing doses of radiotherapy andor relevant systemic treatments in order to determine the IC50 and to obtain dose-response curves of these PDOs to the treatments The investigators will treat the PDOs with the same treatments that the patients had or will receive in order to correlate the responses to radiotherapy andor systemic treatments including immunotherapy co-cultured with immune cells
The response of these PDOs will be compared to the treatment outcome and survivals in these patients
Patient cohorts
1 Breast cancer patients with brain metastases undergoing surgical resection with or without further radiotherapy SRS or whole brain radiotherapy
2 Breast cancer patients with extra-cranial metastases undergoing surgical resection or biopsy
Primary objective
To assess the percentage of successful generated organoids from resected brain or resectedbiopsied extra-cranial metastases of breast cancer patients
Secondary objectives
1 To assess the sensitivity of radiotherapy in PDOs
2 To assess the sensitivity of the same systemic treatments that the patients previously had and will have in PDOs
3 To correlate the treatment sensitivities of PDOs above with the treatment outcome of patients
4 To correlate IC50 dosesdose response curves above with the objective response rates of patients undergoing same systemic treatment
Study Procedures
Breast cancer patients with resectable brain or extra-cranial metastases or who will undergo a biopsy of the extra-cranial metastases will be asked to consent for this study and for their resectedbiopsied samples to be used to generate PDOs The investigators aim to recruit 20 patients in the pilot phase of the study
When the PDOs contain sufficient cells these cells will be treated with increasing doses of radiotherapy andor relevant systemic treatments in order to determine the IC50 and to obtain dose-response curves of these PDOs to the treatments The investigators will treat the PDOs with the same treatments that the patients had or will receive in order to correlate the responses to radiotherapy andor systemic treatments including immunotherapy co-cultured with immune cells
The response of these PDOs will be compared to the treatment outcome and survivals in these patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None