Ignite Creation Date:
2024-05-06 @ 1:15 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03979339
Status:
UNKNOWN
Last Update Posted:
2021-10-13
First Post:
2019-05-27
Brief Title:
Feasibility of a New Technology for Isolating Circulating Tumour Cells
Sponsor:
Centre Oscar Lambret
Organization:
Centre Oscar Lambret
Study Overview
Official Title:
Feasibility of a New Technology for Isolating Circulating Tumour Cells in Selected Cancer Patients and Healthy Volunteers
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
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:
CTC-SMMiL-E
Brief Summary:
This is a prospective interventional single-site research with a collection of biological samples
The primary objective of the trial is to assess the ability of the new technology to isolating circulating tumor cells CTC in selected cancer patients
Five groups will be constitued at first the Group 0 Healthy volunteers included for the spike-in test and then the four groups Group1 Metastatic HER2-positive breast cancer Group 2 Advanced CA-125 positive ovarian cancer Group 3 Metastatic PSA-positive castrate-resistant prostate cancer Group 4 Healthy volunteers included as control
In each group the percentage of cases with identified circulating tumor cells will be estimated
The primary objective of the trial is to assess the ability of the new technology to isolating circulating tumor cells CTC in selected cancer patients
Five groups will be constitued at first the Group 0 Healthy volunteers included for the spike-in test and then the four groups Group1 Metastatic HER2-positive breast cancer Group 2 Advanced CA-125 positive ovarian cancer Group 3 Metastatic PSA-positive castrate-resistant prostate cancer Group 4 Healthy volunteers included as control
In each group the percentage of cases with identified circulating tumor cells will be estimated
Detailed Description:
This is a prospective interventional single-site research with a collection of biological samples Recherche Impliquant la Personne Humaine de type 2 according to French legislation
First a cohort of 20 healthy volunteers Group 0 Healthy volunteers included for the spike-in test will be constituted for the spike-in-test
Then recruitment of the three groups of 14 patients each Group1 Metastatic HER2-positive breast cancer Group 2 Advanced CA-125 positive ovarian cancer Group 3 Metastatic PSA-positive castrate-resistant prostate cancer and the control group of 14 healthy volunteers Group 4 Healthy volunteers included as control will be done in parallel
In each group the percentage of cases with identified circulating tumor cells will be estimated Success will be defined as follows the new technique has isolated putative circulating cells that have been confirmed as tumor cells by the immuno-histochemistry approach
Circulating tumor cells CTC will be identified as followed
Group 1 - putative circulating cells isolated by the new technique must be tested as HER-2 positive using Fluorescence In Situ Hybridization FISH to be regarded as true CTC
Group 2 - putative circulating cells isolated by the new technique must be tested as CA 125-positive using immuno-histochemistry IHC to be regarded as true CTC
Group 3 - putative circulating cells isolated by the new technique must be tested as PSA-positive using IHC to be regarded as true CTC For the healthy volunteers included as controls if putative circulating cells are observed these healthy volunteers will be tested against the three markers HER2 CA-125 and PSA
Failure will be defined as follows the technique failed to identify circulating tumor cells either due to a technical issue or because there was no cell identified by the new technique or lastly because the identified cells were negative by the standard FISH or IHC technique
The different characteristics of these cells will be described size cytological characteristics number etc
Secondary collected samples will be frozen and new technique for isolation of CTC will be applied a second time to describe the impact of freezing to the capacity for isolating the CTC
The primary objective of the trial is to assess the ability of the new technology to isolating circulating tumor cells CTC in selected cancer patients
First a cohort of 20 healthy volunteers Group 0 Healthy volunteers included for the spike-in test will be constituted for the spike-in-test
Then recruitment of the three groups of 14 patients each Group1 Metastatic HER2-positive breast cancer Group 2 Advanced CA-125 positive ovarian cancer Group 3 Metastatic PSA-positive castrate-resistant prostate cancer and the control group of 14 healthy volunteers Group 4 Healthy volunteers included as control will be done in parallel
In each group the percentage of cases with identified circulating tumor cells will be estimated Success will be defined as follows the new technique has isolated putative circulating cells that have been confirmed as tumor cells by the immuno-histochemistry approach
Circulating tumor cells CTC will be identified as followed
Group 1 - putative circulating cells isolated by the new technique must be tested as HER-2 positive using Fluorescence In Situ Hybridization FISH to be regarded as true CTC
Group 2 - putative circulating cells isolated by the new technique must be tested as CA 125-positive using immuno-histochemistry IHC to be regarded as true CTC
Group 3 - putative circulating cells isolated by the new technique must be tested as PSA-positive using IHC to be regarded as true CTC For the healthy volunteers included as controls if putative circulating cells are observed these healthy volunteers will be tested against the three markers HER2 CA-125 and PSA
Failure will be defined as follows the technique failed to identify circulating tumor cells either due to a technical issue or because there was no cell identified by the new technique or lastly because the identified cells were negative by the standard FISH or IHC technique
The different characteristics of these cells will be described size cytological characteristics number etc
Secondary collected samples will be frozen and new technique for isolation of CTC will be applied a second time to describe the impact of freezing to the capacity for isolating the CTC
The primary objective of the trial is to assess the ability of the new technology to isolating circulating tumor cells CTC in selected cancer 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-A01187-50 | OTHER | ANSM | None |