Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Micronutrients

All Drugs and Chemicals

Selenium

Low Dose Selenious Yeast Tablets

High Dose Selenious Yeast Tablets

Zheng Wei, M.D.

Yi-an Zhang, M.D.

Shi-yang Gu, M.D.

The purpose of this study is to evaluate the safety and effectiveness of Selenious Yeast Tablets in Chronic Lymphocytic Leukemia Patients without Indication of Chemotherapy

A large portion of CLL patients has no indications of chemotherapy when diagnosed. In patients with CLL, the mean serum selenium levels are lower than normal. There is a correlation between the selenium level and the clinical stage. We discovered that sodium selenite inhibited the expression of CXCL-1 and restored the defective necroptotic pathway of CLL cells together with TNF-α and z-VAD in vitro. The purpose of this study is to evaluate the safety and effectiveness of Selenious Yeast Tablets in preventing CLL patients without indication of chemotherapy from disease development.

Selenious Yeast in CLL Patients w/o Indication of Chemotherapy

Administration of Selenious Yeast Tablets in Chronic Lymphocytic Leukemia Patients Without Indication of Chemotherapy: A Multicenter Study

Decrease rate of peripheral lymphocyte counts

safety profile of the subjects from enrollment

Shanghai Changzheng Hospital

Shanghai Zhongshan Hospital

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Syndrome

Lymphoma

Lymphoma, Non-Hodgkin

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Immunologic Deficiency Syndromes

Sarcoma

Sarcoma, Kaposi

Lymphoma, AIDS-Related

Neoplasms, Connective and Soft Tissue

Blood-Borne Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Lentivirus Infections

Retroviridae Infections

Virus Diseases

RNA Virus Infections

Genital Diseases

Urogenital Diseases

Slow Virus Diseases

Herpesviridae Infections

DNA Virus Infections

Neoplasms, Vascular Tissue

Lymphoma, B-Cell

Lymphosarcoma

Soft Tissue Sarcoma

Kaposi Sarcoma

B-cell Lymphoma

Antibodies

Immunoglobulins

David A. Wohl

Ann C. Collier

William G. Powderly

Charles S. Rabkin

The purpose of this study is to find out why cancers develop in HIV-positive patients.

Cancer is a leading cause of death in AIDS patients. Common cancers in HIV-infected patients include Kaposi's sarcoma (KS) and non-Hodgkin's lymphoma (NHL), a cancer of the immune system. Risk factors include certain chemicals, viruses, and perhaps even anti-HIV drugs. Doctors would like to find out which risk factors are most important and how they relate to cancer in AIDS patients.

AIDS-associated malignancy represents a model system for investigations of carcinogenesis. There are few human conditions in which cancer rates are of the magnitude they are in HIV infection. While studies have investigated pre-cancer markers in HIV-infected patients, they have not correlated these markers with tumor samples. This study contributes to understanding oncogenesis of HIV-associated malignancies by establishing a collection of tumors linked with pre-cancer sera and lymphocyte specimens, as well as prospective questionnaire data.

At study entry, patients receive a comprehensive physical exam. Clinic staff interview the patient to collect data regarding medication history (particularly antiretroviral exposure), diet, occupational history, substance abuse, and sexual practices. This information is used to identify behavioral and environmental factors contributing to oncogenesis. In addition, baseline blood samples are analyzed for HHV-8 and EBV levels, anti-EBV and anti-HHV-8 antibodies, CD23, Th2 cytokines, tumor growth factors, chromosomal translocations associated with NHL, and other potential predictors of malignancy. At Month 6 and annually thereafter, patient records are abstracted for data on vital status, AIDS-defining illnesses, medications, and most recent CD4+ T cell and HIV RNA levels. At Years 1, 2, and 3, patients undergo physical exams and blood tests for malignancy surveillance. Any malignancies are biopsied and analyzed for oncogene identification and virology. The medical records of patients who die on study are reviewed to determine the cause of death and to rule out unreported cancer. No treatment is provided by this study.

A Study of Patients With AIDS Syndrome

Oncogenic Viral Pathogenesis and Cancer Risk Factors Among Patients With the Acquired Immunodeficiency Syndrome: A Prospective Cohort Study

National Cancer Institute (NCI)

National Institute of Allergy and Infectious Diseases (NIAID)

Patients referred to the oncology / radiation oncology departments for palliative therapy.

There are no specific interventions in this observational study

no specific interventions

Stephan Gripp, Dr.

The accuracy of clinical survival estimates is tested in comparison to objective prognostic scores.

* At presentation a clinical survival estimate is obtained in each patient.
* Survival is also estimated using published prognostic scores in palliative care.
* Prognostic scores based on blood samples, general symptoms, complaints, and performance status are calculated and validated, respectively
* Each patient completes questionnaires on psychological distress
* Survival estimates are limited to 6 months.
* Each patient is followed for at least 6 months.

Prognosis and Survival Estimates in Palliative Therapy

Prognosis in Palliative Therapy - a Prospective Study on Survival Prognostication in Advanced Stage Cancer Patients

Heinrich-Heine University, Duesseldorf

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

Lisa Rydén, Prof

Tor Svensjö, PhD

Kim Gulis, MD

Prospective study of cosmetic outcome and quality of life for women undergoing breast cancer surgery using patient a reported outcome measure (BREAST-Q) and a computer program validated to assess cosmetic outcomes after breast cancer surgery (BCCT.core) at baseline and on 1-year follow-up.

This is a clinical study with the aim to investigate how breast cancer patient's quality of life changes after breast cancer surgery, as well as looking at the cosmetic outcomes for the same patient group. The study is conducted prospectively, with patients being included forward in time when they are diagnosed with breast cancer in Kristianstad hospital, Sweden. The study started in January 2019 and is expected to continue enrollment for two years, with the aim of recruiting 300 patients. The patients fill out a quality of life questionnaire (Breast-Q) at baseline, which is defined as time of diagnosis, and second Breast-Q questionnaire 1-year post surgery. Photos are also taken of the breasts both preoperatively and postoperatively and the photos are assessed by a computer program validated to assess cosmetic outcomes after breast cancer surgery, called BCCT.core, and secondly the cosmetic results of the breasts are evaluated by the surgeon and patient herself on a 10-grade scale. In addition study specific items covering for example psychiatric comorbidity, BMI and smoking are retrieved.

The study hypothesis is that patients undergoing breast cancer surgery overall have a good quality of life 1-year after their diagnosis, especially if they are treated with a surgical approach that takes into account both the best oncological treatment as well as the best surgical technique for cosmetic outcome, so called oncoplastic surgery. The other hypothesis is that cosmetic results will be overall favorable for the group of patients who are operated with breast-conserving techniques, and most favorable in those patients who have undergone oncoplastic surgery. Secondly the study aims to see if there are other patient related variables that affect the quality of life or cosmetic outcome, for example cytostatic treatment, a high body mass index, smoking or psychiatric history prior to diagnosis.

Aspects of Breast-conserving Surgery

Prospective Study of Cosmetic Outcome and Quality of Life for Women Undergoing Breast Cancer Surgery

Breast-Q questionnaire to evaluate quality of life and satisfaction with outcome for the patient.Score 0-100, higher score indicates a better outcome. There is also an additional QoL questionnaire at 1-year follow up (EORTC QLQ-C30 and QLQ-BR23).

BCCT.core (breast cancer conservation treatment. cosmetic results) program, together with both surgeon's and patient's score to evaluate cosmetic outcome.

BCCT.core scores from 1 to 4. 4 is the worse cosmetic outcome. Patients and surgeon will score from 1-10. Higher score indicates a better cosmetic outcome.

Region Skane

Lund University

Lymphoma, Follicular

Disease Progression

Follicular Lymphoma

Massimo Federico, MD

Philippe Solal-Céligny, MD

Armando Lopez-Guillermo, MD

Peter McLaughlin, MD

Umberto Vitolo, MD

Stefano A. Pileri, MD

The F2-study is a complement of the previous studies of the Follicular Lymphoma Prognostic Factors Project which permitted the development of the Follicular Lymphoma International Prognostic Index (FLIPI).

The F2-study is designed as a prospective collection of information potentially useful to predict the prognosis of newly diagnosed Follicular Lymphoma patients, and its purposes are to validate the FLIPI and to verify whether a prognostic collection of data would allow the development of a more accurate prognostic index.

So far, in patients with lymphoma a variety of studies aimed at the evaluation of prognosis have been conducted. In particular, different demographic, clinical and biological factors have shown a prognostic role in univariate and multivariate analysis, including age, gender, stage, tumor burden, bone marrow involvement, systemic symptoms, Performance status, serum lactate dehydrogenase (LDH) level, anemia, erythrocyte sedimentation rate (ESR) and beta-2 microglobulin.

The combination of those parameters has allowed the identification of several prognostic scores.

Attempts to define prognosis in follicular lymphomas begun in the late '70s. Then, when in 1993 the International Prognostic Index (IPI) was defined for aggressive lymphomas it was also applied to low-grade lymphomas leading to conflicting results, and the need for a prognostic index specifically designed for follicular lymphomas emerged.

A large study on prognosis in patients with follicular lymphoma was performed by the Italian Lymphoma Intergroup that leaded to the definition of the Italian Lymphoma Intergroup (ILI) score, based on 987 patients (Federico M et al. Blood 2000; 95(3):783-789). In 2004 the Follicular Lymphoma International Prognostic Project allowed the definition of a new score on 4167 pts with follicular lymphoma, the Follicular Lymphoma International Prognostic Index (FLIPI) (Solal-Céligny P et al. Blood 2004;104(5):1258-1265). This score is based on the evaluation of age (younger than 60 years vs 60 years or older), Ann Arbor stage (I-II vs III-IV), number of nodal sites (0-4 vs \> 5 or more), Hemoglobin (Hb)level (greater than or equal 12g/dL vs lower than 12g/dL), serum Lactate Dehydrogenase (LDH) (normal vs elevated) and identifies three main groups of patients with different survival:low risk (0-1 factors); intermediate risk (2 factors); high risk (3-5 factors).

Notwithstanding the huge number of patients considered in these studies, all mentioned prognostic scores (IPI, ILI and FLIPI) are based on a retrospective analysis of archive data. This approach can introduce biases that can hamper final results. A first problem is the selection of patients that can be influenced by single institution policy and patient's or physician's related factors. Furthermore, some important variables, such as beta2-microglobulin or Erythrocyte Sedimentation Rate (ESR), that have frequently shown a high prognostic significance in univariate analysis, are hardly included in the final indexes because they are available only in a small number of patients thus loosing their value in multivariate analysis. Then, lacking homogeneous and prospectively defined criteria, retrospective evaluation of some study parameter as for example clinical response cannot be easily defined and all derived endpoints such as Failure Free Survival (FFS)or Progression Free Survival (PFS) may be biased.

Finally the results of a retrospective analysis aiming at the evaluation of survival are dependent on the type of administered treatment and with the recent advent of new drugs such as monoclonal antibodies and purine analogs that can be used also in the elderly patients the role of some established prognostic factor may have changed.

These are the reasons why we thought it would be useful to start a new study based on the prospective registration in a short period of time of patients with follicular lymphoma for whom it would be possible collect an exhaustive set of clinical data and biological information.

Formalin-fixed tissue for central diagnostic pathology review

Study of Prognosis of Follicular Lymphoma Through a Prospective Collection of Data (F2-study)

F2-PROTOCOL: Prospective Collection of Data of Possible Prognostic Relevance in Patients With Follicular Lymphoma

Fondazione Italiana Linfomi - ETS

The International Non-Hodgkin Lymphoma Prognostic Factor Project

Associazione Angela Serra per la ricerca sul cancro

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Zhongtao Zhang

Hongwei Yao

Yishan Liu

1. To establish the Chinese people's own clinical data database of colorectal cancer, reflecting the law and characteristics of colorectal cancer patients in China.
2. Based on colorectal cancer surgery, collect clinical data, especially data on clinical manifestations, complications, laboratory tests, auxiliary examinations, postoperative clinical effects, surgical complications, and colorectal cancer recurrence, so as to lead the direction of clinical practice and academic research of colorectal cancer surgery in China. It provides a certain basis for future research on colorectal cancer.
3. Provide academic consultation and data support to national health authorities.

Chinese Colorectal Cancer Database

Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while \>1mm is negative.

shows the quality of the specimens: grade 1 is bad gross specimen which means incomplete mesorectum and pelvic fascia, and muscle layer can be see \>5mm; grade 3 is high quality gross specimen, which means the specimen is cylindrical, mesorectum and pelvic fascia are complete; grade 2 is between 1and 3.

shows the oncological safety of the surgery by pathological examination. Reports should contain the distance between lower tumor margin and the lower reaction margin.

show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.

preoperative safety containing operation information, complication information.

quality of life contains two scales: Wexner scale and EORTC QLQ-CR29 scale, which show quality of life and the anal function.

Beijing Chao Yang Hospital

Peking University People's Hospital

Peking University Cancer Hospital & Institute

Peking Union Medical College Hospital

The First Hospital of Jilin University

Ruijin Hospital

First Hospital of China Medical University

Beijing Friendship Hospital

Director of general surgery, principal investigato

Gland and Hormone Related Diseases

Nervous System Diseases

Pancreatic Neoplasms

Gastroparesis

Pancreatic Diseases

Stomach Diseases

Paralysis

Neurologic Manifestations

Pancreatic Cancer

Open pancreatoduodenectomy with Braun enteroenterostomy

Participants will undergo open pancreatoduodenectomy (PD). The reconstruction technique will not be standardized. In addition to the reconstruction technique used, a side-to-side anastomosis will be created between the afferent and efferent jejunal limbs of the gastrojejunostomy (GJ) at 20 cm distance from the GJ. The anastomosis will be hand-sewn with monofilament PDS 3-0 one-layer running suture.

Braun anastomosis

Participants will undergo open pancreatoduodenectomy (PD). The reconstruction technique will not be standardized. The surgeon is able to perform the PD as normally would be done (antecolic, retrocolic, pylorus-preserving or with distal gastric resecting).

Standard Child reconstruction

Bo TM Strijbos, MD

M G Besselink

M F Gerhards

I de Hingh

M Liem

J M Klaase

E R Manusama

J SD Mieog

M den Dulk

H C van Santvoort

B TM Strijbos

B Groot Koerkamp

V B Nieuwenhuijs

Martijn WJ Stommel, MD, PhD

The goal of this clinical trial (REMBRANDT) is to evaluate the effectiveness of adding an extra connection (i.e. 'Braun anastomosis') after standard reconstruction in pancreatic head resection in reducing the incidence of delayed gastric emptying.

Rationale/hypothesis: The addition of Braun enteroenterostomy (BE) reduces the incidence of delayed gastric emptying (DGE) resulting in lower morbidity and healthcare costs after pancreatoduodenectomy.

Objective: To assess the effectiveness of adding BE in reducing DGE in patients undergoing open pancreatoduodenectomy.

Study design: A multicenter, patient and observer blinded, registry-based randomized controlled trial.

Study population: Patients undergoing an open pancreatoduodenectomy for all indications.

Intervention: Braun enteroenterostomy (BE), or Braun anastomosis, in addition to usual care.

Usual care/comparison: Pancreatoduodenectomy with standard Child reconstruction.

Main endpoints:

1. Incidence of DGE Grade B/C (according to International Study Group of Pancreatic Surgery (ISGPS)
2. Incidence of postoperative pancreatic fistulas (POPF) Grade B/C (according to ISGPS), anastomotic leak, complications, hospital length of stay, functional outcome at 12 months, in-hospital mortality, 30-day mortality, healthcare costs.

Sample size: 256 in total, 128 per arm

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients undergoing open pancreatoduodenectomy have an increased risk of postoperative complications such as DGE, POPF and anastomotic leak. The addition of BE, which is an anastomosis, could also result in a leak. However, this risk is diminishable compared to the risks of DGE and DGE related other complications like anastomotic leaks associated with standard pancreatoduodenectomy. Moreover, previous cohort studies involving BE do not describe an increased risk of adverse outcomes for BE.

Patients will be blinded considering their treatment allocation. The house officer, ward nurses and data managers who extract data concerning the primary and secondary endpoint will be blinded for the allocation as well. For this reason, this will be a patient- and observer blinded RCT.

The Effectiveness of Adding Braun Anastomosis to Standard Child Reconstruction After Pancreatoduodenectomy

The Effectiveness of Adding Braun Anastomosis to Standard Child Reconstruction to Reduce Delayed Gastric Emptying After Pancreatoduodenectomy (REMBRANDT): a Multicenter Randomized-controlled Trial

DGE is defined by the need for maintenance of the nasogastric tube (NGT), need for reinsertion of NGT for persistent vomiting after postoperative day (POD) 7, or inability to tolerate a solid diet.

Any measurable volume of drain output with an amylase level of more than 3 times the upper limit of normal serum amylase and clinically relevant condition or development of the patient directly related to the POPF.

Anastomotic leaks of the hepatojejunostomy (HJ) or Braun enteroenterostomy (BE).

Anastomotic leaks of the HJ manifest as bile leakage. This is defined as "fluid with an increased bilirubin concentration in the abdominal drain or in the intra-abdominal fluid on or after postoperative day 3, or as the need for radiologic intervention because of biliary collections or relaparotomy resulting from bile peritonitis. Increased bilirubin in the drain is defined as bilirubin concentration more than 3 times greater than the serum bilirubin concentration.

An anastomotic leak of the BE is present when an abdominal CT with contrast shows leakage of contrast from the BE or when during relaparotomy dehiscence of the BE is apparent.

Scored according to the modified Clavien-Dindo classification for surgical complications. Grade III and higher are considered clinically relevant in this study.

The time period in days between hospital admission and discharge from the hospital.

Any death occurring 30 days after pancreatoduodenectomy.

The EQ-5D-5L standardized questionnaire will be used.

The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/PAN26 standardized quality of life questionnaires will be used.

The QoR-15 standardized questionnaire will be used.

Participants will be phoned to assess whether they have complaints of delayed gastric emptying ("afferent loop syndrome").

Rising Tide Foundation

Radboud University Medical Center

Wounds and Injuries

Postoperative Complications

Hernia

Rectal Neoplasms

Rectal Diseases

Patients over 18 years of age operated for locally advanced anal or rectal cancer with robot-assisted abdomino-perinal resection and robot-assisted reconstruction of pelvic floor and/or vagina with vertical rectus abdomínis muscle flap.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Selenious Yeast in CLL Patients w/o Indication of Chemotherapy	NCT05136378	Chronic Lymphoc... Chronic Lymphoc... Chronic Lymphoc... Chronic Lymphoc...	Low Dose Seleni... High Dose Selen...	17 Years - 99 Years	Shanghai Zhongshan Hospital
A Study of Patients With AIDS Syndrome	NCT00001120	Sarcoma, Kaposi Lymphoma, Non-H... HIV Infections Lymphoma, AIDS-...		18 Years -	National Institute of Allergy and Infectious Diseases (NIAID)
Prognosis and Survival Estimates in Palliative Therapy	NCT00871520	Cancer	no specific int...	18 Years -	Heinrich-Heine University, Duesseldorf
Aspects of Breast-conserving Surgery	NCT04227613	Breast Neoplasm Cosmetic Outcom... Quality of Life		18 Years -	Lund University
Aspects of Breast-conserving Surgery	NCT04227613	Breast Neoplasm Cosmetic Outcom... Quality of Life		18 Years -	Lund University
Study of Prognosis of Follicular Lymphoma Through a Prospective Collection of Data (F2-study)	NCT01250223	Lymphoma, Folli...		18 Years -	Associazione Angela Serra per la ricerca sul cancro
Chinese Colorectal Cancer Database	NCT05434026	Colonic Cancer Rectal Cancer Prospective Stu...		-	Beijing Friendship Hospital
The Effectiveness of Adding Braun Anastomosis to Standard Child Reconstruction After Pancreatoduodenectomy	NCT05709197	Pancreatic Dise... Pancreatic Canc... Delayed Gastric...	Braun anastomos... Standard Child ...	18 Years -	Radboud University Medical Center
Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap	NCT05689775	Perineum; Wound Postoperative C... Rectal Neoplasm... Rectus Abdomini... Prospective Stu... Wound Heal Sexual Health	Reconstruction ...	18 Years -	Oslo University Hospital

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