Developing Interinstitutional Multimodality Model for Translational Studies for Cervical Cancer Screening and Treatment: Pragmatic Issues Pertaining to Logistics, Infrastructure and Solutions

Background and context: Cervical cancer claims the life of 67,500 women every year in India. Persistence of HPV leads to the development of high grade CIN which may progress to invasive cancer. Almost 80% of women are infected with the virus in their lifetime but only a small proportion of women progress to develop cervical cancer. In early cervical cancer patients despite surgery about 25% recur and in advanced cervical cancer about 50%-60% women respond to radiotherapy while the rest progress or recur with disease after standard treatment. The risk to progression and failure to treatment is dependent on both viral/tumor and host factors; therefore an integrated approach should be adopted in developing predictive and prognostic biomarkers to address these clinical questions. Aim: Establishing a clinical and translational research model to provide an infrastructure that will facilitate targeted screening and targeted therapeutics in cervical precancer and cancer. Strategy/Tactics: Integration of various premium institutions in the city with their infrastructure to form a “Systems Medicine Cluster” was established to conduct this research. We have adopted a primary HPV screening (HC2 DNA and genotyping) strategy as a clinical protocol and devised SOPS to enable sample collection strategies for several research usage from the same sample including cytology testing, genomics, metabolomics, microbiome, proteomics. Similarly a translational pathway has been created for seamless tissue collection from cancer patients for multidimensional research usage. Collaboration was established between clinicians, scientists, clinical trial coordinators, research nurses, data managers and biobank personnel to orchestrate this working model. Program/Policy process: Collaboration of various institutions to form a “Systems Medicine Cluster” to effectively implement research strategies for cervical cancer screening and treatment. Outcomes: With the help of translation work we intend to identify of viral and host factors which determine the persistence of the HPV in screened women, thereby risk stratifying them for colposcopic evaluation. In women with cervical cancer who are treated with standard care, we expect to identify modifiable tumor or host factors and drug targets that can be used to reduce the risk of recurrence and improve survival. In 3 months of implementation we have screened 260 women in the cervical cancer screening clinic and obtained samples from 190 cervical cancer patients for translational research. All women have also contributed to the collection of vaginal fluid and blood samples for various research protocols associated with cervical cancer. What was learned: These translational studies conducted hand in hand with clinical pathways requires meticulous planning and teamed approach. The formation of the “Systems Medicine Cluster” with different expertise to address clinical strategies has been a successful model.