Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Prevalence of comorbidities as Coronary artery disease, Hypertension , Diabetes Mellitus,Hypothyroidism and Corona Virus Infection will be studied in patients undergoing Oncosurgeries.

In the Preoperative Anaesthesia checkup we will study prevalence of comorbidities as Coronary artery Disease, Hypertension, Diabetes Mellitus , Hypothyroidism and prior Corona Virus Infection in patients undergoing Oncosurgeries

To study comorbidities in patients undergoing Oncosurgeries

Anita Kulkarni, MD

Investigators plan to study the prevalence of comorbidities in patients undergoing oncosurgeries

Plan to study the prevalence of Coronary Artery Disease, Hypertension, Diabetes Mellitus, Hypothyroidism, History of Corona Virus infection in patients undergoing oncosurgeries.

In the Pre anesthesia checkup patients age , sex , Weight in kilograms, Height in centimeters , pulse rate, Blood Pressure will be noted and value\>140/90 mmHg will be taken as hypertensive. History will be obtained about diagnosed Coronary Artery Disease , Diabetes Mellitus, Hypertension , Hypothyroidism , History of previous Corona Virus Infection (RT-PCR Test Positive) .Relevant investigations Electrocardiography and Echocardiography for assessment of Coronary Artery Disease. Fasting or Random Blood Sugar , Thyroid Function Test will be done .

Fasting Blood Sugar \>126 milligram/ Decilitre and Random Blood sugar \>200mg/dL will be taken as diabetic. TSH more than 5 micro IU/mL will be hypothyroid .

Prevalence of Comorbidities in Patients Undergoing Oncosurgeries at Tertiary Cancer Institute in North India.

Prevalence of Comorbidities in Patients Undergoing Oncosurgeries at Tertiary Cancer Institute in North India

Electrocardiography and Echocardiography will be performed.

Investigators will measure Blood Pressure , Blood Sugar , Thyroid Function Test and previous Corona Virus Infection

Random Blood Sugar in milligram/Decilitre will be measured.

Thyroid Stimulating Hormone (TSH) in micro IU / millilitre will be measured.

Rajiv Gandhi Cancer Institute & Research Center, India

Senior Consultant

Neoplasms

Blood and Lymph Conditions

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Renal Insufficiency

Leukemia, Lymphoid

Lymphoma

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Chronic Graft Versus Host Disease

Lymphosarcoma

Chronic Lymphocytic Leukemia

Antineoplastic Agents

Antirheumatic Agents

Bendamustine Hydrochloride

Rituximab

Antineoplastic Agents, Immunological

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Significant comorbidities as defined by Cumulative Illness Rating Score (CIRS) of ≥7.

Significant renal dysfunction defined as CrCL 15-40 mL/min, but not receiving dialysis.

Bendamustine

Alexey V Danilov, MD

This is a non-randomized, open label, dose-ranging study of Bendamustine and Rituximab (BR) in patients with previously untreated or relapsed/refractory Chronic Lymphocytic Leukemia (CLL) who have multiple comorbidities with or without renal insufficiency. These agents are FDA approved for this indication. However, full dose bendamustine is associated with significant hematologic toxicity and a high rate of infectious complications in "unfit" patients and patients with significantly impaired renal function. This study will attempt to optimize and define adequate and safe treatment protocols for these patients with comorbidities and/or renal dysfunction.

The study will accrue two independent patient cohorts which will follow a standard Phase I design. Patients with CLL who have significant comorbidities with or without minor renal dysfunction (CrCL\>40 mL/min) will be accrued onto Cohort 1 of the study. Patients with significant renal dysfunction (CrCL\<40 mL/min) will be accrued onto Cohort 2. Once the maximum tolerated dose (MTD) is determined, two expansion cohorts will be enrolled.

There will be a treatment period of up to six 28-day cycles. On C1D1 all qualifying patients will provide samples for biomarker analysis. Six patients without renal dysfunction and 6 to 9 patients with renal dysfunction will also provide samples for bendamustine PK analysis.

Accrual of both patient cohorts will occur simultaneously and will take place at two centers: Norris Cotton Cancer Center (NCCC) and Dana-Farber Cancer Institute (DFCI). Coordination of accrual to the study cohorts will be centralized at NCCC by Dr. Alexey V. Danilov.

This is a non-randomized open label dose-ranging study of Bendamustine and Rituximab (BR) in patients with previously untreated or relapsed/refractory CLL who have multiple comorbidities (Cumulative Illness Rating Scale \[CIRS\]≥7) with or without renal insufficiency (estimated creatinine clearance \[CrCL\] 15-40 mL/min, but not receiving dialysis).

The study will accrue two independent patient cohorts. Both cohorts will follow a standard 3+3 Phase I design. Once the maximum tolerated dose (MTD) is determined, two expansion cohorts will be enrolled. Dose limiting toxicities (DLT) will be assessed during the 1st cycle of treatment.

Patients with CLL who have significant comorbidities (CIRS≥7; at least one category grade 3-4), with or without minor renal dysfunction (CrCL\>40 mL/min) will be accrued onto Cohort 1 of the study. At dose level 1, patients will receive bendamustine 45 mg/m2 in combination with rituximab (375 mg/m2 with cycle 1 and 500 mg/m2 with subsequent cycles). If safe, the dose of bendamustine will be escalated to 70 mg/m2 (dose level 2). By contrast, dose de-escalation to 25 mg/m2 (dose level -1) will occur in this cohort if DLT's are encountered at dose level 1. Once an MTD is determined an expansion cohort will be accrued at that dose level to allow assessment of DLT's during subsequent cycles.

Because bendamustine has not been formally studied in patients with renal failure and due to the potential for increased frequency of toxic events in such patients, patients with significant renal dysfunction (CrCL 15-40 mL/min, but not receiving dialysis) will be accrued on Cohort 2. DLT's in 0/3 (or ≤1/6) subjects with renal dysfunction at dose level 1 (as above) will permit continued accrual of such subjects onto the expansion cohort (N=10). If unacceptable toxicity is encountered, bendamustine dose will be reduced to 25 mg/m2 (dose level -1), followed by an expansion cohort if safe (10 patients). Dose escalation will not be allowed in this cohort.

Accrual of both patient cohorts will occur simultaneously (see Schema) and will take place at two centers: the ambulatory Hematology Clinics at the Norris Cotton Cancer Center (NCCC) at Dartmouth-Hitchcock Medical Center (DHMC), Lebanon, NH (Lead \[Dartmouth\] Principal Investigator \[Lead PI\] - Alexey Danilov M.D., Ph.D.), and the CLL Center at Dana-Farber Cancer Institute (DFCI), Boston, MA (DFCI Principal Investigator \[DFCI PI\] - Jennifer Brown M.D., Ph.D.). Coordination of accrual to the study cohorts will be centralized at the Norris Cotton Cancer Center/DHMC by Dr. Alexey V. Danilov.

BR in Patients With CLL With Comorbidities and/or Renal Dysfunction

A Dose-Ranging Study of Bendamustine and Rituximab in Chronic Lymphocytic Leukemia (CLL) Patients With Comorbidities and/or Renal Dysfunction

To determine the pharmacokinetic (PK) disposition of reduced dose bendamustine in patients with renal dysfunction (CrCL≤40 mL/min).

To assess whether established biomarkers (chromosomal abnormalities, immunoglobulin heavy chain \[IGHV\] mutational status, ZAP-70 and CD38 expression; p53 mutational status, microRNA expression profile) predict response to BR chemoimmunotherapy in patients with CLL who have significant comorbidities.

To evaluate the safety (MTD) of bendamustine in combination with rituximab in patients with CLL who have multiple comorbidities and/or significant renal dysfunction.

To evaluate the efficacy of BR in patients with CLL who have multiple comorbidities and/or significant renal dysfunction.

National Cancer Institute (NCI)

Dartmouth-Hitchcock Medical Center

Professor of Medicine and of Pharmacology and Toxicology

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Analyze comorbidities and patterns of use of health services. Describe the specific use of health services in primary care vs. specialized care.

Analyze comorbidities and patterns of use of health services by tumor characteristics.

Analyze comorbidities and patterns of use of health services. Describe the specific use of health services in primary care vs. specialized care.

The increased likelihood of survival can be explained by numerous factors, such as improvements in breast cancer screening and advances in diagnosis and treatment and aging. This phenomenon is associated with comorbidity due to cancer treatment and external factors like aging or lifestyle. Little is known about how these women follow-up their disease, their pattern of use of health resources and their met and unmet needs. Studying the health needs of these women is a cancer-related priority for Cancer Organizations.The project is aimed at: 1) Describing the comorbidities and patterns of use of primary and specialized care in women who have survived a breast cancer for at least five years; 2) Comparing the comorbidities and patterns of use of long time breast cancer survivors with women without a cancer diagnosis; and 3) Estimating the use of resources in long time survivors of breast cancer adjusted for survival-time and comorbidities.

The general objective of this study is to analyze the pattern of comorbidities and utilization of primary care officers and specialized attention of long-term breast cancer survivors and to compare it with women without history of cancer. Long-term breast cancer survivors are those women who survived for at least five years since de primary breast cancer diagnosis.The use of health care services for long-term breast cancer survivors presents new challenges for health systems in terms of defining the role of each health professional and each level of care in contact with these women during their follow-up.

The SURBCAN Project is an observational study that includes a retrospective cohort of women from five Spanish areas. The study is based on Real World Data from clinical history and tumor registration. Women with a diagnosis of breast cancer and a survival period of ≥ 5 years were identified, as well as those women without a cancer diagnosis and matched by age and area with breast cancer survivors (1:2). N= 21639 women (7241 cases /13,398 controls). Sociodemographic and clinical variables were included. The use of primary care and hospital attention and the presence of comorbidities were assessed during the follow-up period (2012-2016). The basal cohort, the comorbidities and the use of health services were described. Factors associated with use were analyzed through multi-level logistic regression models.

Expected results: Nowadays there are no results of cohort analysis that focus specifically in long-term breast cancer survivors. The SURBCAN study will provide evidence regarding comorbidity patterns and follow-up characteristics. The results will guide the elaboration of new recommendations and the decision making by stakeholders concerned to breast cancer survivor's follow-up.

This project combines the experience from experts groups in health services assessment, and analysis of comorbidities and chronic diseases, belonging to the REDISSEC network.

Long-term breast cancer survivors (women who survived at least 5 years from the diagnosis)

Comorbidities and Health Care Services Utilisation Among Long-term Breast Cancer Survivors

Number of comorbidities of each woman at five-year survival from breast cancer. Assessed through ICD10.

Number of visits to primary care attention or specialised attention done by each women at five-year survival from breast cancer.

Leading provider of health services (GP, oncologist, community nurse, oncology nurse, physiotherapist...) of each women at five-year survival from breast cancer.

Number of visits to primary care attention done by each women at five-year survival from breast cancer.

Number of visits to specialised attention done by each women at five-year survival from breast cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prevalence of Comorbidities in Patients Undergoing Oncosurgeries at Tertiary Cancer Institute in North India.	NCT05038501	Comorbidities a...	To study comorb...	35 Years - 80 Years	Rajiv Gandhi Cancer Institute & Research Center, India
BR in Patients With CLL With Comorbidities and/or Renal Dysfunction	NCT01832922	Chronic Lymphoc... Small Lymphocyt...	Bendamustine Rituximab	18 Years -	Dartmouth-Hitchcock Medical Center
BR in Patients With CLL With Comorbidities and/or Renal Dysfunction	NCT01832922	Chronic Lymphoc... Small Lymphocyt...	Bendamustine Rituximab	18 Years -	Dartmouth-Hitchcock Medical Center
Prevalence of Comorbidities in Patients Undergoing Oncosurgeries at Tertiary Cancer Institute in North India.	NCT05038501	Comorbidities a...	To study comorb...	35 Years - 80 Years	Rajiv Gandhi Cancer Institute & Research Center, India
Prevalence of Comorbidities in Patients Undergoing Oncosurgeries at Tertiary Cancer Institute in North India.	NCT05038501	Comorbidities a...	To study comorb...	35 Years - 80 Years	Rajiv Gandhi Cancer Institute & Research Center, India
Comorbidities and Health Care Services Utilisation Among Long-term Breast Cancer Survivors	NCT03846999	Breast Cancer		18 Years -	Parc de Salut Mar

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