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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A01187-50 | Other Identifier | ANSM |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| blood sample collection | Experimental | For all participants whatever the group Groups 0 and 4: Healthy volunteers Group1: Metastatic HER2-positive breast cancer Group 2: Advanced CA-125 positive ovarian cancer Group 3: Metastatic PSA-positive castrate-resistant prostate cancer Participants will receive the following interventions because they are enrolled in the study: blood sample collection of 32mL (4x8mL in EDTA tubes) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample collection | Procedure | A total volume of 32 ml of blood will be collected in each subject and separated in 4 10-mL EDTA vacutainer tubes EDTA tubes of 8 mL each. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of cases with identified circulating tumor cells. | To assess the ability of the "new technology" to isolating circulating tumor cells (CTC) in selected cancer patients. In each group, the percentage of cases with identified circulating tumor cells will be estimated. Success: the technique has isolated putative circulating cells that have been confirmed as tumor cells by the immuno-histochemistry approach. Failure: 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. To be regarded as true CTC, Putative circulating cells isolated by the new technique must be tested as:
| within 24 hours after inclusion (blood sample collection) |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the isolated circulating cell | Describe the different characteristics of these cells: size, cytological characteristics, number ... These informations will allow to characterize the isolated circulating cells. | within 24 hours after inclusion (blood sample collection) |
| Percentage of cases with identified circulating tumor cells after frozen storage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie Vanseymortier | Contact | +33 (0)3 20 29 59 18 | promotion@o-lambret.fr |
| Name | Affiliation | Role |
|---|---|---|
| Emilie KACZMAREK, MD | Medical Oncology Department - Centre Oscar Lambret | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Recruiting | Lille | 59020 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22733306 | Background | Bednarz-Knoll N, Alix-Panabieres C, Pantel K. Plasticity of disseminating cancer cells in patients with epithelial malignancies. Cancer Metastasis Rev. 2012 Dec;31(3-4):673-87. doi: 10.1007/s10555-012-9370-z. | |
| 15501967 | Background | Allard WJ, Matera J, Miller MC, Repollet M, Connelly MC, Rao C, Tibbe AG, Uhr JW, Terstappen LW. Tumor cells circulate in the peripheral blood of all major carcinomas but not in healthy subjects or patients with nonmalignant diseases. Clin Cancer Res. 2004 Oct 15;10(20):6897-904. doi: 10.1158/1078-0432.CCR-04-0378. |
| Label | URL |
|---|---|
| Circulating tumor cells: potential markers of minimal residual disease in ovarian cancer? a study of the OVCAD consortium | View source |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D009360 | Neoplastic Cells, Circulating |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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To assess the ability of the new technology to isolating CTC As secondary collected, 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 our capacity for isolating the CTC. In each group, the percentage of cases with identified circulating tumor cells will be estimated. To be regarded as true CTC, Putative circulating cells isolated by the new technique must be tested as:
|
| within 24 hours after inclusion (blood sample collection) |
| 15317891 | Background | Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91. doi: 10.1056/NEJMoa040766. |
| 15735118 | Background | Cristofanilli M, Hayes DF, Budd GT, Ellis MJ, Stopeck A, Reuben JM, Doyle GV, Matera J, Allard WJ, Miller MC, Fritsche HA, Hortobagyi GN, Terstappen LW. Circulating tumor cells: a novel prognostic factor for newly diagnosed metastatic breast cancer. J Clin Oncol. 2005 Mar 1;23(7):1420-30. doi: 10.1200/JCO.2005.08.140. |
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| 22683404 | Background | Cen P, Ni X, Yang J, Graham DY, Li M. Circulating tumor cells in the diagnosis and management of pancreatic cancer. Biochim Biophys Acta. 2012 Dec;1826(2):350-6. doi: 10.1016/j.bbcan.2012.05.007. Epub 2012 Jun 7. |
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| The added value of circulating tumor cells examination in ovarian cancer staging | View source |
| Vimentin and Ki67 expression in circulating tumour cells derived from castrate-resistant prostate cancer | View source |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |