Malignant tumor of biliary tract (disorder)

ABC-07- Addition of stereotactic body radiotherapy to systemic chemotherapy in locally advanced biliary tract cancers

Year Started: 2015

• Archival paraffin-embedded tissue - a representative archival block of the tumour tissue from a biopsy or prior surgery. • Whole blood for ctDNA - will be collected at 4 time points, Pre-treatment, end of cycle 4, completion of treatment and at 6 month follow up or at disease progression. • Whole blood for germline DNA- will be collected from patients pre-treatment (within 14 days prior to starting CisGem). • Serum samples (optional for trial sites)- will be collected a 4 different time points, Pre-treatment, end of cycle 4, completion of treatment and at 6 month follow up or at disease progression.



Access:
Closed to access
Type:
Disease specific
Status:
In progress
Consent restrictions:
No restrictions


Associated Data Type Procurement Timeframe
Clinical records 3 - 6 months
Followup records 3 - 6 months
Freezer temperature logs > 6 months
Treatment records 3 - 6 months


Male

Adult (> 40 years)

11 - 100 donors

Material Type Extraction Procedure Storage Temperature Preservation Type Macroscopic Assessment % of Sample Set
Tissue specimen RT Paraffin Not applicable 51 - 75%
Serum -60°C to -85°C Not applicable 51 - 75%
Plasma -60°C to -85°C Not applicable 51 - 75%
Peripheral blood mononuclear cells (PBMC) -60°C to -85°C Not applicable 75% -99%

Malignant tumor of biliary tract (disorder)

ABC-03 -

Year Started: 2011

Randomised phase II trial of cediranib (AZD2171) vs. placebo in addition to cisplatin / gemcitabine chemotherapy for patients with advanced biliary tract cancers



Access:
Access restricted at present
Type:
Clinical Trial
Status:
Completed
Consent restrictions:
Other animal work restriction, Outside EU access restriction, Xenograft restriction


Associated Data Type Procurement Timeframe
Biomarker datasets 0 - 3 months
Clinical records 0 - 3 months
Followup records 0 - 3 months
Imaging data 0 - 3 months
Pathology records 0 - 3 months
Quality indicators 0 - 3 months
Treatment records 0 - 3 months


Male

Adult (> 40 years)

11 - 100 donors

Material Type Extraction Procedure Storage Temperature Preservation Type Macroscopic Assessment % of Sample Set
Tissue specimen Surgical procedure (procedure) RT Paraffin Not applicable 0 - 10%


Female

Adult (> 40 years)

11 - 100 donors

Material Type Extraction Procedure Storage Temperature Preservation Type Macroscopic Assessment % of Sample Set
Peripheral blood mononuclear cells (PBMC) -60°C to -85°C N/A Not applicable 0 - 10%
Plasma -60°C to -85°C N/A Not applicable 0 - 10%
Tissue specimen Surgical procedure (procedure) RT Paraffin Not applicable 0 - 10%


Male

Adult (> 40 years)

11 - 100 donors

Material Type Extraction Procedure Storage Temperature Preservation Type Macroscopic Assessment % of Sample Set
Peripheral blood mononuclear cells (PBMC) -60°C to -85°C N/A Not applicable 0 - 10%
Plasma -60°C to -85°C N/A Not applicable 0 - 10%

Malignant tumor of biliary tract (disorder)

ABC-04

Year Started: 2012

Samples taken from the ABC-04 trial: A phase Ib study of cisplatin, gemcitabine and selumetinib in patients with advanced biliary tract cancers.



Access:
Access restricted at present
Type:
Clinical Trial
Status:
Completed
Consent restrictions:
Outside EU access restriction, Xenograft restriction


Associated Data Type Procurement Timeframe
Biomarker datasets 0 - 3 months
Clinical records 0 - 3 months
Followup records 0 - 3 months
Imaging data 0 - 3 months
Pathology records 0 - 3 months
Treatment records 0 - 3 months


Male

Adult (> 40 years)

1 - 10 donors

Material Type Extraction Procedure Storage Temperature Preservation Type Macroscopic Assessment % of Sample Set
Peripheral blood mononuclear cells (PBMC) -60°C to -85°C N/A Not applicable 0 - 10%
Plasma -60°C to -85°C N/A Not applicable 0 - 10%
Tissue specimen Surgical procedure (procedure) RT Paraffin Not applicable 0 - 10%

Malignant tumor of biliary tract (disorder)

ABC-07- Addition of stereotactic body radiotherapy to systemic chemotherapy in locally advanced biliary tract cancers (Copy 1)

Year Started: 2015

• Archival paraffin-embedded tissue - a representative archival block of the tumour tissue from a biopsy or prior surgery. • Whole blood for ctDNA - will be collected at 4 time points, Pre-treatment, end of cycle 4, completion of treatment and at 6 month follow up or at disease progression. • Whole blood for germline DNA- will be collected from patients pre-treatment (within 14 days prior to starting CisGem). • Serum samples (optional for trial sites)- will be collected a 4 different time points, Pre-treatment, end of cycle 4, completion of treatment and at 6 month follow up or at disease progression.



Access:
Closed to access
Type:
Disease specific
Status:
In progress
Consent restrictions:
No restrictions


Associated Data Type Procurement Timeframe
Clinical records 3 - 6 months
Followup records 3 - 6 months
Freezer temperature logs > 6 months
Treatment records 3 - 6 months


Male

Adult (> 40 years)

11 - 100 donors

Material Type Extraction Procedure Storage Temperature Preservation Type Macroscopic Assessment % of Sample Set
Tissue specimen RT Paraffin Not applicable 51 - 75%
Serum -60°C to -85°C Not applicable 51 - 75%
Plasma -60°C to -85°C Not applicable 51 - 75%
Peripheral blood mononuclear cells (PBMC) -60°C to -85°C Not applicable 75% -99%

Malignant tumor of biliary tract (disorder)

ABC-07- Addition of stereotactic body radiotherapy to systemic chemotherapy in locally advanced biliary tract cancers

Year Started: 2015

• Archival paraffin-embedded tissue - a representative archival block of the tumour tissue from a biopsy or prior surgery. • Whole blood for ctDNA - will be collected at 4 time points, Pre-treatment, end of cycle 4, completion of treatment and at 6 month follow up or at disease progression. • Whole blood for germline DNA- will be collected from patients pre-treatment (within 14 days prior to starting CisGem). • Serum samples (optional for trial sites)- will be collected a 4 different time points, Pre-treatment, end of cycle 4, completion of treatment and at 6 month follow up or at disease progression.



Access:
Closed to access
Type:
Disease specific
Status:
In progress
Consent restrictions:
No restrictions


Associated Data Type Procurement Timeframe
Clinical records 3 - 6 months
Followup records 3 - 6 months
Freezer temperature logs > 6 months
Imaging data 3 - 6 months
Treatment records 3 - 6 months


Male

Adult (> 40 years)

11 - 100 donors

Material Type Extraction Procedure Storage Temperature Preservation Type Macroscopic Assessment % of Sample Set
Tissue specimen RT Not applicable 51 - 75%
Serum -60°C to -85°C Not applicable 51 - 75%
Plasma -60°C to -85°C Not applicable 51 - 75%
Whole blood -60°C to -85°C Not applicable 51 - 75%


Male

Young adult (18 - 40 years)

1 - 10 donors

Material Type Extraction Procedure Storage Temperature Preservation Type Macroscopic Assessment % of Sample Set
Whole blood -60°C to -85°C Not applicable 51 - 75%
Tissue specimen RT Paraffin Not applicable 51 - 75%
Plasma -60°C to -85°C Not applicable 51 - 75%
Serum -60°C to -85°C Not applicable 51 - 75%


Female

Adult (> 40 years)

11 - 100 donors

Material Type Extraction Procedure Storage Temperature Preservation Type Macroscopic Assessment % of Sample Set
Serum -60°C to -85°C Not applicable 51 - 75%
Tissue specimen RT Paraffin Not applicable 51 - 75%
Plasma -60°C to -85°C Not applicable 51 - 75%
Whole blood -60°C to -85°C Not applicable 51 - 75%