Abstract：
:The office of the Drugs Controller General (India) vide order dated 19 th November 2013 has made audio visual (AV) recording of the informed consent mandatory for the conduct of all clinical trials in India. We therefore developed a standard operating procedure (SOP) to ensure that this is performed in compliance with the regulatory requirements, internationally accepted ethical standards and that the recording is stored as well as archived in an appropriate manner. The SOP was developed keeping in mind all relevant orders, regulations, laws and guidelines and have been made available online. Since, we are faced with unique legal and regulatory requirements that are unprecedented globally, this SOP will allow the AV recording of the informed consent to be performed, archived and retrieved to demonstrate ethical, legal and regulatory compliance. We also compared this to the draft guidelines for AV recording dated 9 th January 2014 developed by Central Drugs Standard Control Organization. Our future efforts will include regular testing, feedback and update of the SOP.
journal_name
Indian J Cancerjournal_title
Indian journal of cancerauthors
Parikh PM,Prabhash K,Govind KB,Digumarti R,Pandit S,Banerjee I,Biyani R,Deshmukh A,Doval D,Bhattacharyya GS,Gupta Sdoi
10.4103/0019-509X.138158subject
Has Abstractpub_date
2014-04-01 00:00:00pages
113-6issue
2eissn
0019-509Xissn
1998-4774pii
IndianJournalofCancer_2014_51_2_113_138158journal_volume
51pub_type
杂志文章abstract：BACKGROUND:Nonsmall cell lung cancer is the leading cause of cancer mortality worldwide because of distant metastasis and frequent recurrence. Only few reliable and easily accessible tumor markers have been clinically implemented to the early nonsmall cell cancer prognosis. OBJECTIVE:The purpose of this study is to de...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：10.4103/0019-509X.172509
更新日期：2015-12-01 00:00:00
abstract：:Alpha-fetoprotein secreting (AFP) Sertoli-Leydig cell tumors of ovary (SLCT) are now identified as a distinct entity among the uncommon group of sex cord tumors of ovary. We report an unusual case of recurrent AFP secreting ovarian tumors and as ileocecal mesenteric cyst in a 25-year-old patient resulting in difficult...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：10.4103/0019-509x.48599
更新日期：2009-01-01 00:00:00
abstract：:In most parts of the world, tobacco is used for smoking, whereas, in India, tobacco is used for smoking as well as in diverse smokeless forms. Absorption of toxic and carcinogenic chemicals in tobacco and other ingredients added to various products are causally associated with several non-communicable diseases includi...
journal_title：Indian journal of cancer
pub_type： 杂志文章,评审
doi：10.4103/0019-509X.107735
更新日期：2012-10-01 00:00:00
abstract：:We have studied fibrinolytic activity of 12 cases of infiltrating duct carcinoma of breast (7 metastatic and 5 non-metastatic) and ten cases of adenocarcinoma of gastrointestinal tract (5 each of metastatic and nonmetastatic), and compared with some of their normal tissue counterparts. Both metastatic and non-metastat...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：
更新日期：1991-12-01 00:00:00
abstract：BACKGROUND:We have reported here the 5-year incidence (2004-2008) of gallbladder cancer (GBC) in North Central India along with its descriptive epidemiology. This provides potential clues for better prevention. The present study has also evaluated the association of ABO blood groups with GBC. PATIENTS AND METHODS:The ...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：10.4103/0019-509X.176736
更新日期：2015-07-01 00:00:00
abstract：BACKGROUND:Plasma cell leukemia (PCL) is a rare aggressive variant of multiple myeloma (MM) characterized by a fulminant course and poor prognosis. Flow cytometry (FCM) is very useful in the diagnosis of the plasma cell leukemia. Herein, we present 10 cases of PCL. MATERIALS AND METHODS:We retrospectively studied immu...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：10.4103/0019-509X.134605
更新日期：2014-01-01 00:00:00
abstract：:A composite tumour of the caecum and colon, comprising of distinct areas of classical carcinoid and of well differentiated adenocarcinoma is described. Both components were histochemically confirmed. Presence of a morphologic transition at junctional areas favour a histogenesis from bi-directional differentiation of m...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：
更新日期：1994-09-01 00:00:00
abstract：:The mucoepidermoid carcinoma (MEC) account for approximately 6-8 Percent of all salivary gland tumors. Central mucoepidermoid carcinoma of the jaws is rare. Following is a case report of central mucoepidermoid carcinoma which involves the ramus of the mandible. Origin of the central mucoepidermoid carcinoma is discuss...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：
更新日期：2000-06-01 00:00:00
abstract：:Casual Interpretation of results in a given article has several pitfalls. In order to assess the strengths and limitations of a given article several factors need to be considered. This review article is intended to list, classify and describe briefly the factors that should be considered in the evaluation of an artic...
journal_title：Indian journal of cancer
pub_type： 杂志文章,评审
doi：
更新日期：1999-06-01 00:00:00
abstract：BACKGROUND:Gastrointestinal tract (GI) is the most frequently involved extra nodal site in non-Hodgkin's lymphoma (NHL). Surgery, radiotherapy and chemotherapy (CT) have been used mostly in various combinations, but lately chemotherapy alone has emerged as an effective option. The purpose of this study is to evaluate e...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：10.4103/0019-509x.25773
更新日期：2006-01-01 00:00:00
abstract：CONTEXT:Use of neoadjuvant chemotherapy (NACT) in locally advanced breast cancer (LABC) enables tumor reduction and conservative surgery. It is proposed in some studies that there may be an alteration in the hormonal receptor (HR) status and human epidermal growth factor receptor 2 (Her-2)/neu immune-expression followi...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：10.4103/0019-509X.200669
更新日期：2016-07-01 00:00:00
abstract：:Isolated central nervous metastasis is rare in patients with Ewing's sarcoma. Here we report two cases with CNS metastasis as the sole manifestation of relapse with a brief review of the literature. ...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：
更新日期：1997-03-01 00:00:00
abstract：BACKGROUND:Metaplastic breast carcinoma (MBC) is a rare disease with incidence of less than 1%. MBC present with a larger tumor size, less number of nodes involved, mostly undifferentiated triple negative tumors. We aimed to determine progression-free and overall survival and reported hospital-based incidence of MBC. ...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：10.4103/ijc.IJC_731_18
更新日期：2019-04-01 00:00:00
abstract：PURPOSE:The aim was to evaluate the safety, feasibility and efficacy of computed tomography (CT)-guided percutaneous interstitial brachytherapy using radioactive iodine-125 ( 125 I) seeds for the treatment of lung cancer. MATERIALS AND METHODS:Included in this study were 45 male and 35 female patients aged 52-85 years...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：10.4103/0019-509X.151999
更新日期：2015-02-01 00:00:00
abstract：BACKGROUND:Chronic myeloid leukemia (CML), is the first malignancy that related to the chromosomal abnormality and include 15-20% of all adulthood leukemia. AIMS:This study aimed to compare the hematologic, breakpoint cluster region-abelson (BCR-ABL) and liver function enzymes changes during treatment period of Imatin...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：10.4103/0019-509X.176715
更新日期：2015-07-01 00:00:00
abstract：INTRODUCTION:In our center, we routinely use CCNU (Lomustine) as salvage treatment in high-grade glioma patients who cannot afford bevacizumab. This exploratory analysis was done to report the efficacy and toxicity associated with this regimen. METHODS:Patients who were treated with salvage CCNU (postexposure to temoz...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：10.4103/0019-509X.204774
更新日期：2016-10-01 00:00:00
abstract：:The clinical microbiology department at CMC&H, Vellore in conjunction with the haematology department carries out routine surveillance of patients admitted to the hematology department. Since 1994 in a sample population of 55 patients with various underlying clinical conditions who have had bone marrow transplant, sep...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：
更新日期：2000-03-01 00:00:00
abstract：BACKGROUND:Recent studies indicate neoadjuvant chemotherapy (NACT) can result in R0 resection in a substantial proportion of patients with technically unresectable oral cavity cancers. However, data regarding the efficacy and safety of docetaxel, cisplatin and 5 fluorouracil (TPF) NACT in our setting is lacking. The pr...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：10.4103/0019-509X.134649
更新日期：2014-01-01 00:00:00
abstract：:This report documents the occurrence of an extragonadal malignant teratoma on the sole of the foot, in a young male. The patient also developed a groin nodule showing the same histology. The testes, retroperitoneum and mediastinum, which are usual sites of germ cell tumours were all normal, and no other primary could ...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：
更新日期：1992-06-01 00:00:00
abstract：BACKGROUND:Ephrin A4 is one of the ephrin ligand molecules belonging to the tyrosine kinases receptor family. It was originally identified in a T-lymphoma cell line and seen to be expressed in human adult tissue as well as several tumor types. In our previous study, we showed the unique pattern of ephrin A4 immunohisto...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：10.4103/0019-509X.58859
更新日期：2010-01-01 00:00:00
abstract：:Colloid cyst is a rare benign intracranial neoplasm, commonly located in the third ventricle. Though headache and visual symptoms are classical, the patients may present with sudden neurological deterioration. We present a ten-year-old male child who presented with sudden neurological deterioration due to colloid cyst...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：
更新日期：2003-01-01 00:00:00
abstract：:We present an interesting case of port site metastasis is a menopausal women subsequent to diagnostic laparoscopy undertaken for chronic pelvic pain, which later proved early ovarian malignancy as the source of primary. While cases of port site metastasis have mostly occurred after extensive disease the possbility of ...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：
更新日期：2001-03-01 00:00:00
abstract：INTRODUCTION:: Indian families are known for adopting the role of caregiver naturally when someone in the family falls ill to cancer. Although there were strong family structure and system existed here, now the changing family pattern and structure are challenging the role of cancer caregiving as well. OBJECTIVE:: Thi...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：10.4103/ijc.IJC_211_17
更新日期：2017-04-01 00:00:00
abstract：BACKGROUND:Non-urothelial bladder tumors (NUBTs) are uncommon accounting for approximately 10% of the total urinary bladder tumors while 90% are urothelial in origin. There are very limited comprehensive studies on NUBTs. AIMS AND OBJECTIVES:The objectives of the study were to analyze the clinicopathological and immun...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：10.4103/ijc.IJC_459_17
更新日期：2019-07-01 00:00:00
abstract：:Lymphnode infarction is seen in two sets of situations viz. spontaneous banal infarction of non-neoplastic nodes, and in association with lymphoma. It needs to be differentiated from other causes of lymphnode as a phenomenon occurring synchronous with and occasionally preceding diagnosis of lymphoma is significant. ...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：
更新日期：1989-12-01 00:00:00
abstract：:We report a rare case of 'metastatic invasive mole' to the spinal cord causing paraplegia in a 19-year-old woman. There are no such histologically proven reports in the literature since the use of the tumour marker, beta-subunit of human chorionic gonadotrophin (beta-HCG) and chemotherapy. We stress the importance of ...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：
更新日期：1999-06-01 00:00:00
abstract：:The use of cell phones is increasing worldwide at a phenomenal pace. While cellular communication has dramatically influenced our lifestyle, its impact on human health has not been completely assessed. Widespread concern continues in the community about the deleterious effects of radiofrequency radiations (with which ...
journal_title：Indian journal of cancer
pub_type： 杂志文章,评审
doi：10.4103/0019-509x.48589
更新日期：2009-01-01 00:00:00
abstract：:A rare morphological variant of acute lymphoblastic leukaemia in a ten years old child is described. Ninety five percent of the lymphoblasts had significant number of course granules in the cytoplasm. Diagnostic and prognostic significance of this variant is discussed. ...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：
更新日期：1989-03-01 00:00:00
abstract：BACKGROUND:Increasing incidence of squamous cell carcinoma (SCC) of the oral cavity and oropharynx is reported in young adults. However, there is a paucity regarding etiology and risk factors. AIM:To evaluate the exposure potential carcinogenic factors among a sample aged 45 years and younger, diagnosed with SCC of th...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：10.4103/0019-509X.197725
更新日期：2016-04-01 00:00:00
abstract：PURPOSE:The aim of this prospective study was to evaluate the effects of radiotherapy (RT) on psychiatric disorder in patients undergoing RT for head and neck cancer. MATERIALS AND METHODS:The prospective study included 51 patients with head and neck cancer. The diagnosis of psychiatric disorder was made by Diagnostic...
journal_title：Indian journal of cancer
pub_type： 杂志文章
doi：10.4103/0019-509X.180816
更新日期：2016-01-01 00:00:00
