Journal Article
. 2008 Sep;14(18).
doi: 10.1158/1078-0432.CCR-08-1267.

Translational Research Working Group developmental pathway for biospecimen-based assessment modalities

Sudhir Srivastava 1 Joe W Gray  Brian J Reid  Oren Grad  Addison Greenwood  Ernest T Hawk  Translational Research Working Group  
Affiliations
  • PMID: 18794074
  •     9 References
  •     11 citations

Abstract

The Translational Research Working Group (TRWG) was created as a national initiative to evaluate the current status of National Cancer Institute's investment in translational research and envision its future. The TRWG conceptualized translational research as a set of six developmental processes or pathways focused on various clinical goals. One of those pathways describes the development of biospecimen-based assays that use biomarkers for the detection, diagnosis, and prognosis of cancer and the assessment of response to cancer treatment. The biospecimen-based assessment modality pathway was conceived not as comprehensive description of the corresponding real-world processes but rather as a tool designed to facilitate movement of a candidate assay through the translational process to the point where it can be handed off for definitive clinical testing. This paper introduces the pathway in the context of prior work and discusses key challenges associated with the biomarker development process in light of the pathway.

The development of a multitarget, multicolor fluorescence in situ hybridization assay for the detection of urothelial carcinoma in urine.
I A Sokolova, K C Halling, +4 authors, W King.
J Mol Diagn, 2001 Mar 07; 2(3). PMID: 11229514    Free PMC article.
Phases of biomarker development for early detection of cancer.
M S Pepe, R Etzioni, +5 authors, Y Yasui.
J Natl Cancer Inst, 2001 Jul 19; 93(14). PMID: 11459866
Highly Cited. Review.
Vysis UroVysion for the detection of urothelial carcinoma.
Kevin C Halling.
Expert Rev Mol Diagn, 2003 Jul 25; 3(4). PMID: 12877389
Rules of evidence for cancer molecular-marker discovery and validation.
David F Ransohoff.
Nat Rev Cancer, 2004 Apr 02; 4(4). PMID: 15057290
Highly Cited. Review.
The Translational Research Working Group developmental pathways: introduction and overview.
Ernest T Hawk, Lynn M Matrisian, +7 authors, Translational Research Working Group.
Clin Cancer Res, 2008 Jul 10; 14(18). PMID: 18612047
A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer.
Soonmyung Paik, Steven Shak, +12 authors, Norman Wolmark.
N Engl J Med, 2004 Dec 14; 351(27). PMID: 15591335
Highly Cited.
Bias as a threat to the validity of cancer molecular-marker research.
David F Ransohoff.
Nat Rev Cancer, 2005 Feb 03; 5(2). PMID: 15685197
Highly Cited. Review.
Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer.
Soonmyung Paik, Gong Tang, +11 authors, Norman Wolmark.
J Clin Oncol, 2006 May 25; 24(23). PMID: 16720680
Highly Cited.
Enzymatic production of single-stranded DNA as a target for fluorescence in situ hybridization.
H van Dekken, D Pinkel, J Mullikin, J W Gray.
Chromosoma, 1988 Jan 01; 97(1). PMID: 3191791
The Translational Research Working Group developmental pathway for anticancer agents (drugs or biologics).
Richard L Schilsky, Gary Gordon, +5 authors, Translational Research Working Group.
Clin Cancer Res, 2008 Sep 17; 14(18). PMID: 18794076    Free PMC article.
Biobanking of human pancreas cancer tissue: impact of ex-vivo procurement times on RNA quality.
Udo Rudloff, Umesh Bhanot, +4 authors, Peter J Allen.
Ann Surg Oncol, 2010 Feb 18; 17(8). PMID: 20162455    Free PMC article.
Re: Joseph Chin. In Search of the Perfect Crystal Ball for Ta Urothelial Cancer. Eur Urol. doi:10.1016/j.eururo.2009.09.014.
Anirban P Mitra, Marc Birkhahn, Richard J Cote.
Eur Urol, 2010 Mar 09; 57(1). PMID: 20208982    Free PMC article.
Interphase cytogenetics of sputum cells for the early detection of lung carcinogenesis.
Sheila A Prindiville, Thomas Ried.
Cancer Prev Res (Phila), 2010 Mar 25; 3(4). PMID: 20332302    Free PMC article.
Review.
New paradigms in translational science research in cancer biomarkers.
Paul D Wagner, Sudhir Srivastava.
Transl Res, 2012 Mar 20; 159(4). PMID: 22424436    Free PMC article.
Review.
Translational spinal cord injury research: preclinical guidelines and challenges.
Paul J Reier, Michael A Lane, +2 authors, Dena R Howland.
Handb Clin Neurol, 2012 Oct 27; 109. PMID: 23098728    Free PMC article.
Review.
ERCC1 and XRCC1 as biomarkers for lung and head and neck cancer.
Alec Vaezi, Chelsea H Feldman, Laura J Niedernhofer.
Pharmgenomics Pers Med, 2011 Jan 01; 4. PMID: 23226053    Free PMC article.
Cancer biomarkers: are we ready for the prime time?
Alok Mishra, Mukesh Verma.
Cancers (Basel), 2010 Jan 01; 2(1). PMID: 24281040    Free PMC article.
Genetic Insights in Barrett's Esophagus and Esophageal Adenocarcinoma.
Brian J Reid, Thomas G Paulson, Xiaohong Li.
Gastroenterology, 2015 Jul 26; 149(5). PMID: 26208895    Free PMC article.
Review.
Molecular substratification of bladder cancer: moving towards individualized patient management.
Anirban P Mitra.
Ther Adv Urol, 2016 Jun 02; 8(3). PMID: 27247631    Free PMC article.
Review.
Imaging biomarker roadmap for cancer studies.
James P B O'Connor, Eric O Aboagye, +74 authors, John C Waterton.
Nat Rev Clin Oncol, 2016 Nov 03; 14(3). PMID: 27725679    Free PMC article.
Highly Cited. Review.