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Conference Paper: The PARSC trial, a prospective study for the assessment of recurrence risk in stage II colon cancer patients using ColoPrint
Title | The PARSC trial, a prospective study for the assessment of recurrence risk in stage II colon cancer patients using ColoPrint |
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Authors | |
Keywords | Medical sciences Oncology medical sciences Radiology and nuclear medicine pharmacy and pharmacology biology Cytology and histology |
Issue Date | 2012 |
Publisher | American Society of Clinical Oncology. The Journal's web site is located at http://www.jco.org/ |
Citation | The 2012 Annual Meeting of the American Society of Clinical Oncology® (ASCO 2012), Chicago, IL., 1-5 June 2012. In Journal of Clinical Oncology, 2012, v. 30 n. 15 suppl., abstract no. TPS10632 How to Cite? |
Abstract | BACKGROUND: An 18-gene expression profile, ColoPrint, has been developed for identifying colon cancer patients more likely to develop recurrent disease and who would be candidates for adjuvant chemotherapy. The gene signature was validated in public datasets and independent patient cohorts (stage II and III patients). Uni-and multivariate analysis was performed on the pooled stage II patient set (n=320) (median follow-up 70 months). ColoPrint classifies 65% of stage II patients as Low Risk. The 3-year RFS was 91% for Low Risk and 74% for High Risk patients with a HR of 2.9 (p=0.001). ColoPrint was the only significant prognostic marker in the subgroup of patients with T3-MSS phenotype (Tabernero, ASCO GI 2012). METHODS: A blinded prospective trial, PARSC (Prospective study for the Assessment of Recurrence risk in Stage II colon cancer patients) using ColoPrint has been initiated. Objectives are: (1)To validate the performance of ColoPrint in estimating the 3-year relapse rate in patients with stage II colon cancer. (2) To compare the risk assessment in stage II patients using the ColoPrint profile vs a clinical risk assessment based on Investigator’s assessment of risk and ASCO high-risk recommendations. (3) To investigate therapy as a potential confounding factor for ColoPrint results. (4) To assess the performance of ColoPrint in estimating the 3-year relapse rate in patients with stage III colon cancer. Inclusion criteria: age ≥ 18 years, adenocarcinoma of the colon, stage II and III, no prior neo-adjuvant therapy, no synchronous tumors, fresh tumor sample, and written informed consent. The treatment of the patient is at the discretion of the physician adhering to National Comprehensive Cancer Network (NCCN)-approved regimens or a recognized alternative (blinded for ColoPrint result). The trial started in Sept. 2008 with currently 32 participating sites in 11 countries. Thus far, 340 eligible stage II and 280 stage III patients have been enrolled. The aim is to enroll 575 stage II patients. Clinical trial registry number: NCT00903565. |
Description | General Poster Session - Tumor Biology: abstract no. TPS10632 - http://meetinglibrary.asco.org/content/97780-114 |
Persistent Identifier | http://hdl.handle.net/10722/153149 |
ISSN | 2023 Impact Factor: 42.1 2023 SCImago Journal Rankings: 10.639 |
DC Field | Value | Language |
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dc.contributor.author | Salazar, R | en_US |
dc.contributor.author | Marshall, J | en_US |
dc.contributor.author | Capdevila, J | en_US |
dc.contributor.author | Glimelius, B | en_US |
dc.contributor.author | de Waard, JW | en_US |
dc.contributor.author | Van Der Hoeven, J | en_US |
dc.contributor.author | Klaase, J | en_US |
dc.contributor.author | Bibeau, F | en_US |
dc.contributor.author | Bachleitner-Hofmann, T | en_US |
dc.contributor.author | Midgley, RA | en_US |
dc.contributor.author | Levine, EA | en_US |
dc.contributor.author | Law, WL | en_US |
dc.contributor.author | Asano, M | en_US |
dc.contributor.author | Chang, GJ | en_US |
dc.contributor.author | Cohen, SM | en_US |
dc.contributor.author | Beart, RW | en_US |
dc.contributor.author | Goldfarb, PM | en_US |
dc.contributor.author | McCarter, M | en_US |
dc.contributor.author | Stork-Sloots, L | en_US |
dc.contributor.author | Rosenberg, R | en_US |
dc.date.accessioned | 2012-07-16T09:58:07Z | - |
dc.date.available | 2012-07-16T09:58:07Z | - |
dc.date.issued | 2012 | en_US |
dc.identifier.citation | The 2012 Annual Meeting of the American Society of Clinical Oncology® (ASCO 2012), Chicago, IL., 1-5 June 2012. In Journal of Clinical Oncology, 2012, v. 30 n. 15 suppl., abstract no. TPS10632 | en_US |
dc.identifier.issn | 0732-183X | - |
dc.identifier.uri | http://hdl.handle.net/10722/153149 | - |
dc.description | General Poster Session - Tumor Biology: abstract no. TPS10632 - http://meetinglibrary.asco.org/content/97780-114 | - |
dc.description.abstract | BACKGROUND: An 18-gene expression profile, ColoPrint, has been developed for identifying colon cancer patients more likely to develop recurrent disease and who would be candidates for adjuvant chemotherapy. The gene signature was validated in public datasets and independent patient cohorts (stage II and III patients). Uni-and multivariate analysis was performed on the pooled stage II patient set (n=320) (median follow-up 70 months). ColoPrint classifies 65% of stage II patients as Low Risk. The 3-year RFS was 91% for Low Risk and 74% for High Risk patients with a HR of 2.9 (p=0.001). ColoPrint was the only significant prognostic marker in the subgroup of patients with T3-MSS phenotype (Tabernero, ASCO GI 2012). METHODS: A blinded prospective trial, PARSC (Prospective study for the Assessment of Recurrence risk in Stage II colon cancer patients) using ColoPrint has been initiated. Objectives are: (1)To validate the performance of ColoPrint in estimating the 3-year relapse rate in patients with stage II colon cancer. (2) To compare the risk assessment in stage II patients using the ColoPrint profile vs a clinical risk assessment based on Investigator’s assessment of risk and ASCO high-risk recommendations. (3) To investigate therapy as a potential confounding factor for ColoPrint results. (4) To assess the performance of ColoPrint in estimating the 3-year relapse rate in patients with stage III colon cancer. Inclusion criteria: age ≥ 18 years, adenocarcinoma of the colon, stage II and III, no prior neo-adjuvant therapy, no synchronous tumors, fresh tumor sample, and written informed consent. The treatment of the patient is at the discretion of the physician adhering to National Comprehensive Cancer Network (NCCN)-approved regimens or a recognized alternative (blinded for ColoPrint result). The trial started in Sept. 2008 with currently 32 participating sites in 11 countries. Thus far, 340 eligible stage II and 280 stage III patients have been enrolled. The aim is to enroll 575 stage II patients. Clinical trial registry number: NCT00903565. | - |
dc.language | eng | en_US |
dc.publisher | American Society of Clinical Oncology. The Journal's web site is located at http://www.jco.org/ | - |
dc.relation.ispartof | Journal of Clinical Oncology | en_US |
dc.subject | Medical sciences | - |
dc.subject | Oncology medical sciences | - |
dc.subject | Radiology and nuclear medicine pharmacy and pharmacology biology | - |
dc.subject | Cytology and histology | - |
dc.title | The PARSC trial, a prospective study for the assessment of recurrence risk in stage II colon cancer patients using ColoPrint | en_US |
dc.type | Conference_Paper | en_US |
dc.identifier.email | Law, WL: lawwl@hkucc.hku.hk | en_US |
dc.identifier.authority | Law, WL=rp00436 | en_US |
dc.description.nature | link_to_OA_fulltext | - |
dc.identifier.hkuros | 201000 | en_US |
dc.identifier.volume | 30 | - |
dc.identifier.issue | 15 suppl. | - |
dc.publisher.place | United States | - |
dc.identifier.issnl | 0732-183X | - |