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Circulating Tumour DNA as a Marker of Occult Disease in Stage II Colorectal Cancer and Response to Therapy in Metastatic Colorectal Cancer

ABSTRACT: Interventions: This is a prospective study involving the collection of blood samples for the purposes of measuring circulating tumour DNA from two distinct cohorts of patients: COHORT A: Patients with curatively resected stage II colon cancer- subgroups will be enrolled according to whether adjuvant chemotherapy is recommended by patient’s treating oncologist. Group A - Chemotherpay; Group B - No Chemo (serial blood collection) and Group C - No chemotherapy (baseline sample). Timepoints for each group in COHORT A are as follows: Group A - 60mls of blood will be collected at 11 timepoints- Timepoint 1 - Baseline (4-8 weeks post operation) Timepoint 2 - Post 3 month of chemotherapy Timepoint 3 - Completion of chemotherapy Timepoint (4 - 11) -3 monthly follow ups post completion of treatment (3mths; 6mths; 9mths; 12mths; 15mths; 18 mths; 21 mnths and 24mths) Group B - 60mls of blood will be collected at 9 timepoints - Timepoint 1 - Baseline (4-8 weeks post operation) Timepoint (2 - 9) -3 monthly follow ups post completion of treatment (3mths; 6mths; 9mths; 12mths; 15mths; 18 mths; 21 mnths and 24mths) Group C - 60mls of blood will be collected at 1 timepoint - Timepoint 1 Baseline (4-8 weeks post operation) COHORT B - Patients with metastatic (stage IV) colorectal cancer undergoing first line chemotherapy. 60 mls of blood will be collected at 3 timepoints - Timepoint 1 - Priot to Cycle 1 Day 1 chemotherapy Timepoint 2 - Cycle 1 Day 3 chemotherapy Timepoint 3 - Cycle 2 Day 1 cemotherapy Primary outcome(s): COHORT A Stage II Colrectal Cancer - to demonstrate that persistence of tumour derived DNA in peripheral blood following complete resection of the primary tumour is a sensitive and specific arker of subsequent disease recurrence.[COHORT A - At the completion of the analysis of blood, plasma and tissue samples. COHORT A are as follows: Group A - 60mls of blood will be collected at 11 timepoints- Timepoint 1 - Baseline (4-8 weeks post operation) Timepoint 2 - Post 3 month of chemotherapy Timepoint 3 - Completion of chemotherapy Timepoint (4 - 11) -3 monthly follow ups post completion of treatment (3mths; 6mths; 9mths; 12mths; 15mths; 18 mths; 21 mnths and 24mths) Group B - 60mls of blood will be collected at 9 timepoints - Timepoint 1 - Baseline (4-8 weeks post operation) Timepoint (2 - 9) -3 monthly follow ups post completion of treatment (3mths; 6mths; 9mths; 12mths; 15mths; 18 mths; 21 mnths and 24mths) Group C - 60mls of blood will be collected at 1 timepoint - Timepoint 1 Baseline (4-8 weeks post operation)];COHORT B Stage IV Colorectal Cancer - To confirm that early changes in the level of circulating tumour DNA are a sensitive and specific marker of treatment response or resistance.[COHORT B - At the completion of the analysis of blood, plasma and tissue samples. COHORT B - Patients with metastatic (stage IV) colorectal cancer undergoing first line chemotherapy. 60 mls of blood will be collected at 3 timepoints - Timepoint 1 - Priot to Cycle 1 Day 1 chemotherapy Timepoint 2 - Cycle 1 Day 3 chemotherapy Timepoint 3 - Cycle 2 Day 1 cemotherapy] Study Design: Timing: Prospective

DISEASE(S): Measuring Cancer Specific Gene Changes In The Blood As A Biomarker In Monitoring Disease Status In Stage Ii And Iv Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2458038 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: This is a prospective study involving the collection of blood samples for the purposes of measuring circulating DNA from patients with resectable colorectal cancer liver metastases. Two distinct cohorts of patients, those undergoing initial liver resection followed by 12 cycles of FOLFOX and those given pre and postoperative chemotherapy will be treated and followed according to standard protocols. 60 mls of blood will be collected at specified timpoints. - 60 mls will be collected at each timepoint. COHORT 1 - Initial Surgery the timepoints are: Timepoint 1 - Screening Timepoint 2 - 4 weeks post surgery Timepoint 3 Post cycle 6 adjuvant chemotherapy (Day 1 Cycle 7) Timepoint 4 - Post cycle 12 (Days 3 at CADD disconnect) Timepoint 5 - 10 every 3 months (3 mth follow up; 6mth follow up; 12 mth follow up; 18 mth follow up and 24 mth follow up) COHORT 2 - Pre-op Chemo timpoints are: Timepoint 1 - Screening Timepoint 2 - Post cycle 1 (day 1 cycle 2) Timepoint 3 - Post cycle 2 (day 1 cycle 3) Timepoint 4 - post cycle 4 (day 1 cycle 5) Timepoint 5 - 4 weeks post surgery Timepoint 6 - Post cycle 12 (day 3 at CADD disconnect) Timepoint 7 -10 - 3 monthly follow - ups ( 3 mths; 6 mths; 9 mths; 12 mnths) Timepoint 11 & 12 - 6 monthly follow - ups (18 mths and 24 mths) Primary outcome(s): To demonstrate that the persistence of tumour DNA in peripheral blood immediately following clinically and radiologically complete resection of liver metastases is a sensitive and specific predictor of subsequent disease recurrence.[Final analysis of blood, plasma and tissue specimens. COHORT 1 - Initial Surgery the timepoints are: Timepoint 1 - Screening Timepoint 2 - 4 weeks post surgery Timepoint 3 Post cycle 6 adjuvant chemotherapy (Day 1 Cycle 7) Timepoint 4 - Post cycle 12 (Days 3 at CADD disconnect) Timepoint 5 - 10 every 3 months (3 mth follow up; 6mth follow up; 12 mth follow up; 18 mth follow up and 24 mth follow up) COHORT 2 - Pre-op Chemo timpoints are: Timepoint 1 - Screening Timepoint 2 - Post cycle 1 (day 1 cycle 2) Timepoint 3 - Post cycle 2 (day 1 cycle 3) Timepoint 4 - post cycle 4 (day 1 cycle 5) Timepoint 5 - 4 weeks post surgery Timepoint 6 - Post cycle 12 (day 3 at CADD disconnect) Timepoint 7 -10 - 3 monthly follow - ups ( 3 mths; 6 mths; 9 mths; 12 mnths) Timepoint 11 & 12 - 6 monthly follow - ups (18 mths and 24 mths)]

Project description:The investigation includes findings from our clinical trial, monitoring individualized response to pneumococcal vaccination, where we have carried out integrative profiling on peripheral blood mononuclear cells (PBMCs) and saliva pre and post vaccination in a single individual. This is to our knowledge the most extensive saliva-centered omics dataset on an individual, covering 100 timepoints over the course of one year. The time span covers a healthy period as well as comprehensive monitoring of innate and adaptive immune responses following pneumococcal vaccination. Protein and RNA from saliva and PBMCs were produced at each timepoint (100 timepoints for saliva, 25 for PBMCs), and mass spectrometry proteomics and RNA-sequencing were carried out for all samples in non-targeted comprehensive profiling. Specifically, a single individual (male, 38) was profiled over multiple timepoints during healthy periods, as well as post treatment with pneumococcal vaccine (PPSV23). Initially pre-immunization samples, including a 24 hour period with hourly sampling (samples P1052515H07-P1052615H08), were collected to provide a comparative baseline. A subsequent 24-hour time course was performed, with again hourly samples taken pre and post vaccination (P1060715H07-P1060815H06). The PPSV23 pneumococcal vaccine was admistered inbetween timepoints at approximately 10.30am, prior to datapoint P1060715H11. Following the vaccination, and after the 24 hour monitoring, daily samples were taken for about a month (up to sample P1070715H08), to capture innate and adaptive responses in saliva. Two more weekly samples followed, with then monthly sample till the end of the investigation. Concurrently, weekly or monthly PBMC samples were taken. Omics sample analysis includes: RNA-sequencing of total RNA in saliva and PBMCs. small RNA sequencing in saliva. Proteomics in saliva and PBMCs. small RNA from extracellular vesicles in saliva. Note on sample naming: The sample identifier/name P1MMDDYYHhh corresponds to: patient index:P1, date MMDDYY and hour hh preceded by H using 24hour enumeration. Overall the study produced 100 timepoints for saliva in the span of a year, as well as 30 PBMC samples.

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Circulating Tumour DNA as a Marker of Occult Disease in Stage II Colorectal Cancer and Response to Therapy in Metastatic Colorectal Cancer

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