FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/01/061396 [Registered on: 12/01/2024] Trial Registered Prospectively
Last Modified On: 15/10/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Study of Pre-identified methylation marker gene as a gastric cancer biomarker 
Scientific Title of Study   Validation and establishment of pre-identified novel gene(s) as gastric cancer biomarker(s) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Srimoyee Ghosh 
Designation  Professor 
Affiliation  North Eastern Hill University 
Address  Dept of Zoology,North Eastern Hill University Shillong
North Eastern Hill University
East Khasi Hills
MEGHALAYA
793022
India 
Phone  09774566179  
Fax    
Email  srimoyee2009@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Srimoyee Ghosh 
Designation  Professor 
Affiliation  North Eastern Hill University 
Address  Dept of Zoology,North Eastern Hill University Shillong
North Eastern Hill University
East Khasi Hills
MEGHALAYA
793022
India 
Phone  09774566179  
Fax    
Email  srimoyee2009@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Srimoyee Ghosh 
Designation  Professor 
Affiliation  North Eastern Hill University 
Address  Dept of Zoology,North Eastern Hill University Shillong
North Eastern Hill University
East Khasi Hills
MEGHALAYA
793022
India 
Phone  09774566179  
Fax    
Email  srimoyee2009@gmail.com  
 
Source of Monetary or Material Support  
Department of Zoology, North-Eastern Hill University, Shillong, Meghalaya-793022 
 
Primary Sponsor  
Name  North Eastern Hill University  
Address  Umshing, Mawkynroh, Shillong-793022, Meghalaya,India 
Type of Sponsor  Other [Intramural funding] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gaurav Das   Dr. B. BOROOAH CANCER INSTITUTE   Department of Surgical Oncology, Dr. B. BOROOAH CANCER INSTITUTE,Gopinath Nagar, A K Azad Road, Guwahati-781016
Kamrup
ASSAM 
08638149432

das.drgaurav@gmail.com 
Prof Srimoyee Ghosh  North East Cancer Hospital and Research Institute  Department of Biochemistry, North East Cancer Hospital and Research Institute, 11th Mile Amerigog, Jorabat Guwahati-781023 Assam, India
Kamrup
ASSAM 
09774566179

srimoyee2009@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Dr. B Borooah Cancer Institute Institute Academic Building Gopinath Nagar Guwahati Assam  Approved 
North East Cancer Hospital and Research Institute NECHRI Mezzanine Guwahati Assam India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Gastric cancer patients attending the surgical oncology OPD.
2. Patients who are willing to participate.
3. Age ≥ 18.
 
 
ExclusionCriteria 
Details  1. History of combination of other types of cancer.
2. Non-availability of matched cancer and normal tissue from the same patient.
3. Non-availability of patient data.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Degree of methylation of the proposed genes.
2. Expressional difference of the proposed genes. 
1.1st week of participation:Gene expression analysis.
2.2nd week of participation: Gene methylation analysis. 
 
Secondary Outcome  
Outcome  TimePoints 
Association between the specific gene methylation with TNM status, Personal habits.  3rd week of participation.  
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [srimoyee2009@gmail.com].

  6. For how long will this data be available start date provided 31-12-2023 and end date provided 28-11-2023?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

INTRODUCTION

Epigenetic changes are linked with many cancer types [1]. In GC, Several genes were found to be differentially methylated compared to their adjacent normal cells of the same individual [2], and these differentially methylated genes can be used as a biomarker for GC screening, treatment, and prognosis [3].

In India, GC is responsible for about 53,253 deaths in the year 2020 and is the 6th leading cause of death [4]. 1 out of 160 men and 319 women has the risk to develop GC in their lifetime (0-70 years) [5]. Aizawl and Papumpare district of Mizoram and Arunachal Pradesh respectively has the highest incidence of GC among men and women respectively [6]. Kamrup (metro) of Assam has reported having the highest increase in APC (annual percentage change) of 6.5 in males and 11.7 in females [5].

Five Novel hypermethylated genes (PPP1R16B, FGF12, FEZF2, GDF7, and KCNQ5) were identified in the ethnic population of Mizoram form our laboratory at NEHU [7]. The primary objective of this present study is to establish these 5 genes as biomarker(s) of GC in patients from different ethnicities of Northeast India. These biomarker(s) will help clinicians better understand the disease, diagnose early and design the treatment plan accordingly.

HYPOTHESIS

The hypothesis of the study is PPP1R16B, FGF12, FEZF2, GDF7, and KCNQ5 genes are differentially methylated and have expressional differences between cancer matched-control tissues suggesting their potential utility as biomarkers for the diagnosis and prognosis of gastric cancer for different population.

OBJECTIVES

a.      To study the degree of methylation of PPP1R16B, FGF12, FEZF2, GDF7, and KCNQ5 in cancer and matched control tissue and measure its association with different patient parameters.

b.      To study the expression of PPP1R16B, FGF12, FEZF2, GDF7, and KCNQ5 in cancer and matched control tissue and measure its association with different patient parameters.

c.       To calculate the association between methylation and expression of PPP1R16B, FGF12, FEZF2, GDF7, and KCNQ5 in cancer and matched control tissue.

REFERENCES

[1]   Esteller, M. (2008). Epigenetics in cancer. New England Journal of Medicine, 358(11), 1148–1159.

[2]   Jones, P. A., & Baylin, S. B. (2002). The fundamental role of epigenetic events in cancer. Nature Reviews Genetics, 3(6), 415–428.

[3]   Locke, W. J., Guanzon, D., Ma, C., Liew, Y. J., Duesing, K. R., Fung, K. Y., & Ross, J. P. (2019). DNA methylation cancer biomarkers: Translation to the clinic. Frontiers in Genetics, 1150.

[4]   IARC (2020). Globocan-2020. Retrieved from: https://gco.iarc.fr/today/data/factsheets/populations/356-india-fact-sheets.pdf

[5]   Mathur, P., Sathishkumar, K., Chaturvedi, M., Das, P., Sudarshan, K. L., Santhappan, S., Nallasamy, V., John, A., Narasimhan, S., Roselind, F. S., & others. (2020). Cancer statistics, 2020: Report from national cancer registry programme, India. JCO Global Oncology, 6, 1063–1075.

[6]   Shanker, N., Mathur, P., Das, P., Sathishkumar, K., Shalini, A. M., & Chaturvedi, M. (2021). Cancer scenario in North-East India & need for an appropriate research agenda. The Indian Journal of Medical Research, 154(1), 27.

[7] Lamare, F., Khongsti, S., Marthong, L., Ghosh, S., Chenkual, S., & Dkhar, H. et al. (2022). Genome-wide DNA methylation profiling of stomach cancer in the ethnic population of Mizoram, North East India. Genomics, 114(5), 110478.



 
Close