Symptoms and General Pathology

All Conditions

Substance Related Disorders

Behaviors and Mental Disorders

Nervous System Diseases

Cancer Pain

Constipation

Pain

Opioid-Induced Constipation

Signs and Symptoms, Digestive

Neurologic Manifestations

Narcotic-Related Disorders

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics, Opioid

Clinical assessment (history, examination) is gold standard for diagnosing constipation - gold standard will be compared with simple question about constipation, Rome IV diagnostic criteria for OIC, and common definitions of constipation for constipation / OIC

Clinical assessment

Andrew N Davies, MD

The aim of the project is to investigate opioid-induced constipation (OIC) in a real world / diverse group of patients with cancer.

The objectives of the project are to determine: a) prevalence of OIC; b) clinical features / impact of OIC; c) management of OIC.

StOIC-1 is an observational study, and will involve a single visit (see below for schedule).

The following data will be collected: a) demographic data - age, gender, ethnicity; b) cancer diagnosis; c) opioid medications - drug, formulation, dose; d) laxative medications - drug, formulation, dose; e) other medications; f) Eastern Co-operative Oncology Group performance status

The participants will be asked the following questions:

1. Simple question - "Are you constipated?" \[Options - yes / no / unsure\]
2. European Association for Palliative Care definition question - "Does the following question describe your bowel function: 'the passage of small, hard faeces infrequently and with difficulty?' \[Options - yes / no / unsure\]
3. Camilleri definition question - "Does the following statement describe your bowel function: 'a change since initiating opioid therapy from baseline bowel habits that is characterised by any of the following: reduced bowel movement frequency, development or worsening of straining to pass bowel movements, a sense of incomplete rectal evacuation, harder stool consistency?' \[Options - yes / no / unsure
4. Rome IV diagnostic criteria for OIC

The participants will also be asked to complete:

1. Bowel function index (BFI). The BFI is a validated, 3 item, patient-reported tool for assessing the treatment of OIC. A BFI score of ≥30 indicates suboptimally treated OIC.
2. Patient Assessment of Constipation - Quality of Life Questionnaire (PAC-QOL). The PAC-QOL is a validated, 28-item, patient-reported tool for assessing the impact of constipation over time.
3. Memorial Symptom Assessment Scale - Short Form (MSAS-SF). The MSAS-SF is a validated, 32 item, patient-reported tool for assessing physical and psychological symptoms in cancer patients.

The participant will also undergo a palliative care specialist assessment for constipation / OIC. The palliative care specialist will be asked to review the patient with regard to their bowel function, and then asked the following questions: a) does the patient have constipation? \[Options - yes / no / unsure\]; b) (if appropriate) does the patient have opioid-induced constipation? \[Options - yes / no / unsure\]; c) (if appropriate) does the patient have additional causes of constipation? \[Options - yes / no / unsure\]; d) (if appropriate) what additional causes of constipation?I

Study of Opioid-Induced Constipation 1 Project

An Observational Study of Diagnostic Criteria, Clinical Features and Management of Opioid-induced Constipation (OIC) in Patients With Cancer Pain

Currently, there are no plans to make IPD available to other researchers

Kyowa Hakko Kirin UK, Ltd.

Royal Surrey County Hospital NHS Foundation Trust

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Keratosis, Actinic

Keratosis

Bowen's Disease

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Skin Diseases

Precancerous Conditions

Lesion with histological confirmation of a actinic keratosis or Bowens disease (non-invasive lesions).

Lesion with histological confirmation of a squamous cell carcinoma (invasive lesions).

Assessment of the lesion with a non-invasive OCT scan according to a confidence scale (5-point Likert scale: 1 Definitely not invasive, 2 Probably not invasive, 3 Unknown invasive or non-invasive, 4 Probably invasive, 5 Definitely invasive)

Optical Coherence Tomography

Clinical assessment of the lesion by a dermatologist according to a confidence scale (5-point Likert scale: 1 Definitely not invasive, 2 Probably not invasive, 3 Unknown invasive or non-invasive, 4 Probably invasive, 5 Definitely invasive)

K Mosterd, MD, PhD

The increasing incidence of actinic keratosis (AK), morbus Bowen (MB) and cutaneous squamous cell carcinoma (cSCC), the patients with often multiple lesions and the disadvantages of invasive diagnostics show the need for an accurate non-invasive diagnostic tool for the determination of invasive growth in AK and MB.

Optical coherence tomography (OCT) is a non-invasive scanner creating cross-sectional images of the skin, to a depth of 1-1,5 mm based on light waves. Until now, OCT has been proposed as non-invasive diagnostic tool for basal cell carcinomas. Although the diagnostic value of OCT for detection and sub-typing of basal cell carcinomas has already been demonstrated, it is unclear whether OCT can discriminate between invasive and non-invasive lesions (AK, MB and cSCCs). There are some studies that describe OCT characteristics of AK, MB and cSCCs, however, these characteristics have a lot of overlap (8-13). To date there are no clearly distinctive OCT features to distinguish between AK, MB and cSCCs. This study aims to investigate the value of OCT in discriminating between the presence and absence of invasion in lesions with clinical suspicion for invasion.

Two experienced OCT-assessors will evaluate the OCT scans independently. The OCT assessors are blinded to the histological diagnosis of the lesions (invasive or non-invasive), which is used as golden standard.

A 5-point Likert scale is used for OCT assessment.

1. Definitely not invasive
2. Probably not invasive
3. Unknown, probably invasive/probably not invasive
4. Probably invasive
5. Definitely invasive

In addition to completing the Likert-scale, assessors are asked to describe the presence/absence of predefined OCT characteristics (a.o. hyperkeratosis and the presence of the dermo-epidermal junction)

In case of disagreement between the independent assessors, the OCT scan will be re-assessed in a consensus meeting.

OCT and Invasion in Cutaneous Skin Lesions

The Value of Optical Coherence Tomography in Discrimination Between the Presence and Absence of Invasion in Clinical Actinic Keratosis

Specificity of OCT in determining the presence/absence of invasion

Negative predictive value of OCT in determining the presence/absence of invasion

Positive predictive value of OCT in determining the presence/absence of invasion

Area under the curve for OCT in determining the presence/absence of invasion

Sensitivity for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.

Difference in diagnostic parameters (sensitivity, specificity and area under the curve) between OCT and clinical practice (clinical assessment).

Specificity for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.

Positive predictive value for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.

Negative predictive value for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.

Area under the curve for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.

Maastricht University Medical Center

Blood and Lymph Conditions

Skin Neoplasms

Lymphedema

Lymphatic Diseases

Patients with any type of skin melanoma (at the level of the lower limb), urogenital or gynaecological cancer scheduled for lymph node dissection

screening of patients at risk for developing unilateral or bilateral lower limb lymphedema

clinical assessment

Tessa De Vrieze, Dr.

Lymphedema is a chronic, debilitating disorder characterized by abnormal tissue swelling, adipose deposition and tissue fibrosis, resulting from disruption, blockage, or genetic abnormalities of the lymphatic system. Secondary lymphedema is an acquired lymphedema due to trauma, surgery, radiotherapy or infection among others resulting in a decreased transport capacity of the lymphatic system. This can be combined with an additional load on the lymphatic system due to obesity, venous hypertension or a wound, among others. Advances in oncologic treatment have led to an ever-increasing number of cancer survivors over time. As a result, morbidities related to this treatment (such as secondary lymphedema) are likely to increase too.

Risk factors for the development of LLL after treatment for (gynaecological) cancer are: pelvic and para-aortic lymphadenectomy, the number of pelvic lymph nodes removed, adjuvant radiotherapy, adjuvant chemotherapy, increasing BMI/ BMI ≥25 kg/m², lymphocyst formation, increasing age, increasing time since surgery and insufficient physical activity level.

To the investigators knowledge, no evidence exists regarding which (combination of) measuring methods are most sensitive to detect early lymphedema at the lower limbs after the treatment of cancer. Thresholds for identifying subclinical edema on one or both lower limbs are lacking.

Therefore the investigators want to develop a screening set for patients at risk for developing LLL. Which measurement method (and which criterion) shows the best diagnostic accuracy in screening patients at risk for LLL after cancer treatment? And: What is the added value of combining different measurement methods in terms of diagnostic accuracy?

Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 2

Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Development of a Screening Set for Patients at Risk for Developing LLL

Sensitivity of reliable and clinical feasible measurement methods (resulted from aim 1: NCT05269264) regarding the screening of patients at risk for developing unilateral or bilateral LLL at 6 weeks, 6, and 12 months post-surgery

Specificity of reliable and clinical feasible measurement methods (resulted from aim 1: NCT05269264) regarding the screening of patients at risk for developing unilateral or bilateral LLL at 6 weeks, 6, and 12 months post-surgery

Diagnostic accuracy of reliable and clinical feasible measurement methods (resulted from aim 1: NCT05269264) regarding the screening of patients at risk for developing unilateral or bilateral LLL at 6 weeks, 6, and 12 months post-surgery

Dependent variable = presence of lower limb lymphoedema Independent variable= Age (years) will be self-reported through interview.

Dependent variable = presence of lower limb lymphoedema Independent variable= Baseline physical activity level : will be assessed with the International Physical Activity Questionnaire (IPAQ).

The IPAQ is a 27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.

Dependent variable = presence of lower limb lymphoedema Independent variable= Educational level: will be self-reported through interview.

Dependent variable = presence of lower limb lymphoedema Independent variable= baseline Body Mass Index

Dependent variable = presence of lower limb lymphoedema Independent variable= baseline comorbidities

Comorbidities will be reported through a self-developed co-morbidity questionnaire, based on IDEWE questionnaire.

Dependent variable = presence of lower limb lymphoedema Independent variable= Type of cancer Information regarding the type of cancer is collected by exploring the patient's medical file.

Dependent variable = presence of lower limb lymphoedema Independent variable= Tumor stage

Information regarding the tumor stage of is collected by exploring the patient's medical file.

Dependent variable = presence of lower limb lymphoedema Independent variable= Lymph node stage

Information regarding the lymph node stage of is collected by exploring the patient's medical file.

Dependent variable = presence of lower limb lymphoedema Independent variable=Number of positive lymph nodes: is collected through the patient's medical file.

Information regarding the complications related to the surgery as well as adjuvant therapies is collected. Surgical complications will be assessed according to the Clavien-Dindo Classification of Surgical Complications.

Cancer treatment characteristics are collected (i.e. type of surgery, type of lymph node dissection, number of lymph nodes removed, presence of postoperative drain, number of positive lymph nodes, adjuvant therapies; by exploring the patient's medical file.

Type of lymph node dissection: Limited- Standard- Extended- Super extended

Cancer treatment characteristics are collected (i.e. type of surgery, type of lymph node dissection, number of lymph nodes removed, presence of postoperative drain, number of positive lymph nodes, adjuvant therapies; by exploring the patient's medical file.

Cancer treatment characteristics , including adjuvant radiotherapy are collected; by exploring the patient's medical file.

Calculation of the proportion of patients with leg (or foot) lymphedema, defined as 5.0% or more increase of the leg (or foot) volume in each leg (or foot), at a certain time point, compared to the volumes at baseline; OR patients with a score of at least 5 out of 52 on the detect-OL questionnaire in case it is clearly indicated whether symptoms are present in one or both legs (in order to be able to categorize patients to the "unilateral LLL" or "bilateral LLL" group).

Additionally, the proportion of presence of LLL in patients having received a lymph node dissection due to gynaecological cancer vs. due to urogenital cancer vs. due to skin melanoma will be compared. The distribution of LLL (unilateral vs. bilateral, regions of the lower limb) will be encountered and compared.

Universitaire Ziekenhuizen KU Leuven

KU Leuven

Post-doctoral research fellow and physiotherapist, PhD in Biomedical Sciences (Catholic University of Leuven) and Medical Sciences (University of Antwerp)

Fatigue

Breast Neoplasms

Carcinoma in Situ

Breast Carcinoma In Situ

Breast Diseases

Anti-Inflammatory Agents

Antirheumatic Agents

Dermatologic Agents

Gastrointestinal Agents

Infliximab

Tumor Necrosis Factor Inhibitors

A single infusion of 1mg/kg will be administered.

infliximab

Medical, psychiatric, and immune evaluation.

Clinical Assessment

Fatigue Symptom Inventory, Multidimensional Fatigue Symptom Inventory, Hamilton Depression Rating Scale, Beck Depression Inventory II, Hamilton anxiety Rating Scale, Pittsburgh Sleep Quality Index, Brief Pain Inventory, MOS SF-36.

Self-report questionnaires

Proinflammatory cytokines and markers of cytokine activity and lymphocyte subsets and CBC.

Immune Assessment

Patricia A. Ganz, MD

RATIONALE: Infliximab may help improve energy levels in patients who have undergone treatment for breast cancer.

PURPOSE: This phase II trial is studying how well infliximab works in treating cancer-related fatigue in postmenopausal women who have undergone treatment for stage 0, stage I, or stage II breast cancer.

OBJECTIVES:

* Determine the association between the body's immune system and energy, sleep, mood, and other symptoms in postmenopausal women who have undergone treatment for stage 0-II breast cancer.
* Determine whether treatment with infliximab affects energy and immune function in these patients.

OUTLINE: Patients receive infliximab IV over 2 hours.

Patients complete a diary twice daily for 14 days before and for 14 days after infliximab administration to assess fatigue and other symptoms, including mood, pain, and sleep.

After completion of study treatment, patients are followed at 2 weeks and then monthly for 3 months.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Infliximab in Treating Cancer-Related Fatigue in Postmenopausal Women Who Have Undergone Treatment for Breast Cancer

Does Blocking Proinflammatory Cytokines Diminish Cancer-Related Fatigue?

American Cancer Society, Inc.

Jonsson Comprehensive Cancer Center

Immune System Diseases

Lymphoma

Hodgkin Disease

Lymphoproliferative Disorders

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

This is a prospective cross-sectional study of 200 HL survivors whose treatment included mediastinal RT at initial diagnosis or relapse, and are at least 5 years from last HL treatment.

HL treatment will be determined by review of available medical records as archived at MSKCC. Recorded variables will include: (1) RT - field, fractional and cumulative dose, and duration; (2) chemotherapy - regimen, planned interval, dose per cycle, and cumulative dosages. Patients will also be asked to complete the FACT-LYM questionnaire and the FACIT Fatigue questionnaire.

Both imaging tests will be performed within a 30 day interval, with the two modalities interpreted by dedicated study investigators blinded to the results of the other modality.

Stress cardiac MRI

Stress echocardiogram

Alison Moskowitz, MD

This study will test whether cardiac MRI can improve early detection of Hodgkin lymphoma associated heart disease compared to a stress echocardiogram. By doing both stress echocardiography and cardiac MRI, we will compare the ability of the two tests to detect heart disease.

Tissue and Functional Assessment of Myocardial Injury in Hodgkin Lymphoma (HL) Survivors

detected by cardiac MRI to that detected by stress echocardiography among a broadly representative cohort of Hodgkin lymphoma survivors.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Opioid-Induced Constipation 1 Project	NCT04350112	Opioid-induced ... Cancer Cancer Pain	Clinical assess...	18 Years -	Royal Surrey County Hospital NHS Foundation Trust
OCT and Invasion in Cutaneous Skin Lesions	NCT06014697	Cutaneous Squam... Bowen's Disease Actinic Keratos... Keratosis, Acti... Diagnosis	Optical Coheren... Clinical assess...	-	Maastricht University Medical Center
Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 2	NCT05421377	Lower Limb Lymp...	clinical assess...	18 Years -	KU Leuven
Infliximab in Treating Cancer-Related Fatigue in Postmenopausal Women Who Have Undergone Treatment for Breast Cancer	NCT00112749	Breast Cancer Fatigue	infliximab Clinical Assess... Self-report que... Immune Assessme...	45 Years - 65 Years	Jonsson Comprehensive Cancer Center
Tissue and Functional Assessment of Myocardial Injury in Hodgkin Lymphoma (HL) Survivors	NCT02106611	Hodgkin Lymphom...	Clinical Assess... Stress cardiac ... Stress echocard...	18 Years -	Memorial Sloan Kettering Cancer Center
Infliximab in Treating Cancer-Related Fatigue in Postmenopausal Women Who Have Undergone Treatment for Breast Cancer	NCT00112749	Breast Cancer Fatigue	infliximab Clinical Assess... Self-report que... Immune Assessme...	45 Years - 65 Years	Jonsson Comprehensive Cancer Center

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