Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Carcinoma

Neoplasm Metastasis

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplastic Processes

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Colchicine

Tubulin Modulators

Antimitotic Agents

2 tablets (0.5 mg/tablet) of colchicine three times per day (after breakfast, lunch and dinner); continue 4 days and stop for 3 days (1 cycle); repeat this cycle until patients quit this trial

Adjustment the dosage of colchicine during study:

The colchicine dosage will be changed when the hepatic reserved function of the participant changes from Child A to B according as following: 2 tablets after breakfast, 1 tablet after lunch and 2 tablets after dinner; continue 4 days and stop for 3 days (1 cycle); repeat this cycle until patients quit this trial. If the hepatic reserved function of the participant changes to Child C, colchicine will be stopped and participant receives regular follow-up only.If participant suffers from severe diarrhea, colchicine will be temporarily stopped. When the symptom of diarrhea subsides, colchicine will be given again but the dose will be reduced 0.5 mg/day.

Zu Y Lin, MS

This trial is to evaluate the potential of colchicine for the palliative management of hepatocellular carcinoma patients with distant metastasis or large vessel invasion using the Department of Health R.O.C. approved doses and methods of administration.

Dosing schedule: 2 tablets (1 mg) three times per day (after breakfast, lunch and dinner); continue 4 days and stop for 3 days (1 cycle)

Adjustment the dosage of colchicine during study:

1. The colchicine dosage will be changed when the hepatic reserved function of the participant changes from Child A to B according to the following rules.

   1. 2 tablets after breakfast, 1 tablet after lunch and 2 tablets after dinner; continue 4 days and stop for 3 days (1 cycle); repeat this cycle until patients quit this trial
   2. If the hepatic reserved function of the participant returns to Child A, The dosage for Child A will be restored.
   3. If the hepatic reserved function of the participant changes to Child C, colchicine will be stopped and participant receives regular follow-up only.
2. If participant suffers from severe diarrhea, colchicine will be temporarily stopped. When the symptom of diarrhea subsides, colchicine will be given again according to the following rules.

   1. For participant receives﹝2 tablets after breakfast, 2 tablet after lunch and 2 tablets after dinner﹞, the dosage of colchicine will be changes to﹝2 tablets after breakfast, 1 tablet after lunch and 2 tablets after dinner﹞.

      If diarrhea attacks again, the dosage of colchicine will be changes to﹝2 tablets after breakfast and 2 tablets after dinner﹞.

      If diarrhea attacks again, the dosage of colchicine will be changes to﹝2 tablets after breakfast, 1 tablet after dinner﹞.

      If diarrhea also attacks again, colchicine will be stopped and participant receives regular follow-up only.
   2. For participant receives﹝2 tablets after breakfast, 1 tablet after lunch and 2 tablets after dinner﹞, the dosage of colchicine will be changes to﹝2 tablets after breakfast and 2 tablets after dinner﹞.

   If diarrhea attacks again, the dosage of colchicine will be changes to﹝2 tablets after breakfast, 1 tablet after dinner﹞.

   If diarrhea also attacks again, colchicine will be stopped and participant receives regular follow-up only.
3. If the participant has one of the following conditions, colchicine will be temporarily stopped. When the condition of the participant improves, colchicine will be given again after the judgment from the doctor of the research team. For participants unable to receive colchicine again, they will receive regular follow-up only.

   1. There are life-threatening hemorrhage including gastrointestinal hemorrhage and hemorrhage from other vital organs such as lungs or brain.
   2. . There are life-threatening bacterial, fungal or viral infection (not included hepatitis B and C virus).
   3. . Patient has serum creatinine level \> 1.5 mg/dL.
   4. . Patient has white blood cell count \< 1500/µL, platelet count \< 30000/µL or hemoglobin \< 9.0 gm/dL after medication.
   5. The research team decides that the participant is not suitable to continue the study caused by abnormality of any vital organ or severe side effects caused by the study.
4. Colchicine will be temporarily stopped one day before transcatheter arterial chemoembolization until participant has body temperature \< 38 ℃, same hepatic reserved function as before, and serum creatinine level \< 1.5 mg/d after embolization.

Follow-up procedures and items for the participants to co-operate:

All participants will be followed according to the guide line of the National Health Council and the clinical practice in the treatment of hepatocellular carcinoma. Contrasted-enhanced computed tomography or magnetic resonance imaging will be performed within every 3 to 4 months. Serum alpha-fetoprotein will be determined at least one session within every 2 to 3 months in patients with elevated serum alpha-fetoprotein levels. The hepatic and renal function will be determined at least one session every month. The participants are asked to visit our outpatient clinic at least one session every month.

Effect of Colchicine for the Palliative Management of Hepatocellular Carcinoma

Evaluation the Potential of Colchicine for the Palliative Management of Hepatocellular Carcinoma Patients With Distant Metastasis or Large Vessel Invasion

The overall survival of the participants calculated from the date of enrollment to the date of death will be compared with the control group with the same TNM and the Barcelona Clinic Liver Cancer (BCLC) staging collected from 2005/1/1 to the end of this study. The overall survival of the control group was calculated from the date of receiving sorafenib treatment to the date of death.

The type and frequency of grade III severe adverse events based on the Common Terminology Criteria for Adverse Events (CTCAE) noted during the study period.

Kaohsiung Medical University Chung-Ho Memorial Hospital

professor

The adverse event for diarrhea was defined as watery or not-formed stool passage for more than 3 times per day.

2 tablets (0.5 mg/tablet) of colchicine three times per day (after breakfast, lunch and dinner); continue 4 days and stop for 3 days (1 cycle); repeat this cycle until patients quit this trial

Colchicine: Adjustment the dosage of colchicine during study:

The colchicine dosage will be changed when the hepatic reserved function of the participant changes from Child A to B according as following: 2 tablets after breakfast, 1 tablet after lunch and 2 tablets after dinner; continue 4 days and stop for 3 days (1 cycle); repeat this cycle until patients quit this trial. If the hepatic reserved function of the participant changes to Child C, colchicine will be stopped and participant receives regular follow-up only.If participant suffers from severe diarrhea, colchicine will be temporarily stopped. When the symptom of diarrhea subsides, colchicine will be given again but the dose will be reduced 0.5 mg/day.

Colchicine Group

The control group was originated from review of hepatocellular carcinoma patients (from January 1, 2014 to May 31, 2019) with the same condition as this trial selected participants and treated by sorafenib for more than 2 months by the research team.

Sorafenib Treated Group

This group included participants receiving total daily colchicine dose equal or larger than 1.5 mg for more than 8 cycles (28 days).

Colchicine Treated Patients

This group was originated from review of hepatocellular carcinoma patients (from January 1, 2014 to May 31, 2019) with the same condition as this trial selected participants and treated by sorafenib for more than 2 months by the research team.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Taiwan

open labeled phase II for AJCC TNM IIIB to IVB hepatocellular carcinoma patient

Region of Enrollment

The participant received more than 8 courses of colchicine management.

Dr. Zu-Yau Lin

Participant received more than 8 courses of colchicine management.

Overall Survival

Comparison the incidence of grade III adverse event of pneumonia between two groups

Comparison the incidence of grade III adverse event of biliary tract obstruction between two groups

Comparison the incidence of grade III adverse event of cholangitis between two groups

Comparison the incidence of grade III adverse event of peritonitis between two groups

Comparison the incidence of grade III adverse event of sepsis between two groups

Comparison the incidence of grade III adverse event of diarrhea between two groups

Comparison the incidence of grade III adverse event of anorexia between two groups

Comparison the incidence of grade III adverse event of abdominal pain between two groups

Comparison the incidence of grade III adverse event of skin rash between two groups

Comparison the incidence of grade III adverse event of palmar-plantar erythrodysesthesia syndrome between two groups

Comparison the incidence of grade III adverse event of hypertension between two groups

Comparison the incidence of grade III adverse event of hemorrhage between two groups

Comparison the incidence of grade III adverse event of hypoglycemia between two groups

Comparison the incidence of grade III adverse event of hyperglycemia between two groups

Comparison the incidence of grade III adverse event of hypocalcemia between two groups

Comparison the incidence of grade III adverse event of pleural effusion between two groups

Diarrhea

Anorexia

Biliary tract obstruction

Abdominal pain

Hypoglycemia

Pneumonia

Peritonitis

Cholangitis

Sepsis

Skin rash

Palmar-plantar erythrodysesthesia syndrome

Hypertension

Hemorrhage

Hyperglycemia

Hypocalcemia

Pleural effusion

This included the events occured after the participant signed the inform consent.

Grade III Severe Adverse Events

The dosing schedule started from 1 mg three times per day after meal for 4 days and stopped for the following 3 days (1 cycle). This cycle was repeated till the participant quitted this trial.

Adjustment of colchicine dosage during study:

1. The colchicine dosage was changed when the hepatic reserved function of the participant changed from Child A to B or C according to the following rules.

   1. Total daily dose reduced to 2.5 mg (1mg morning, 0.5 mg afternoon, 1 mg night) for participant with Child class B.
   2. If the participant changed to Child class C, colchicine will be stopped and participant received regular follow-up only.
2. Colchicine was temporarily stopped in participant suffered from diarrhea and was started again with reducing daily total dose of 0.5 mg.
3. Colchicine was temporarily stopped when the participant fitted any of the exclusion criteria during the study, and was given again after the fitted exclusion criterion was eliminated.

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

immunohistochemical staining, transfection, invasion assay

Torng Pao-Ling, MD, PhD

Torng Pao-Ling, ME, PhD

An ovarian cancer cell line (OVTW-59) derived from an ovarian endometrioid carcinoma was established and its sublines, labeled as P0, P1, P2, P3, and P4 with increasing invasion abilities were selected from transwell invasion chambers.Using cDNA microarray and verified with quantitative reverse-transcriptase polymerase chain reaction, we have identified IGFBP-3 as an invasion-suppressor gene. We plan to study the role of IGFBP-3 in ovarian cancer invasion.

We have successfully established an ovarian cancer cell line (OVTW-59), which was derived from an ovarian endometrioid carcinoma. Its sublines, labeled as P0, P1, P2, P3, and P4 with increasing invasion abilities, were selected from transwell invasion chambers, where P0 represented the original cell line at 100th passage. By using cDNA microarray and verified with quantitative reverse-transcriptase polymerase chain reaction, we have identified the differentially gene expression profiles of these OVTW-59 series cell lines in order to identify the invasion related suppressor and oncogenes from ovarian carcinoma. From these genes, we selected insulin-like growth factor binding protein (IGFBP)-3, which is a suppressor gene, and found it lower expressed in higher-grade tumors and correlated with poor patient survival. In vitro, we found IGFBP-3 related to the inhibition of cancer cell migration. In this study, we plan to setup stable transfected IGFBP-3 cell lines in P0 and P4, and study the relationship among IGFBP-3, metalloproteinase-2 (our previous studies which verified its relationship with tumor invasiveness) and insulin-like growth factor (IGF)-1. We would study the changes in cytoskeletal structures and the known functions of anti-proliferation and apoptosis in IGFBP-3. Furthermore, we would like to investigate the mechanism of IGFBP-3 in the inhibition of invasion/migration of ovarian carcinoma, either signaling through MAPK or PI3K/AKT pathways. Finally, through xenograft, we plan to study for the possible application of IGFBP-3 in ovarian cancer therapy.

IGFBP-3 in Ovarian Cancer Invasion

Study of IGFBP-3 in the Ovarian Carcinoma Cell Invasion

National Taiwan University Hospital

Skin and Connective Tissue Diseases

Carcinoma, Squamous Cell

Keratosis, Actinic

Keratosis

Bowen's Disease

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)

Clinical assessment

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

Carcinoma, Endometrioid

immunohistochemical, methylation, gene transfection

We have identified insulin-like growth factor binding protein (IGFBP)-3 as an invasion suppressor gene in ovarian endometrioid carcinoma, and showed association with lower cancer migration, invasion and metastasis. Recently, a novel model of ovarian EC formation from endometriosis was reported, and PTEN was found to be a major protein involved. Inactivation of PTEN has been reported in some ovarian EC tumors and methylation was suggested as one of the major epigenetic changes. This tumorigenesis model has lots of similarity to our established invasion model. Therefore, we plan to study the important of PTEN expression in ovarian EC and if inactivation of PTEN and IFGBP-3 is through methylation. Furthermore, by studying the signal transduction pathways using PTEN and IGFBP-3 transfection, we plan to study the mutual interaction between PTEN and IGFBP-3 on the suppression of tumor invasion in ovarian EC.

We have successfully established an ovarian cancer cell line (OVTW-59), which was derived from an ovarian endometrioid carcinoma (EC), and have also established an ovarian EC invasion model. By using cDNA microarray and quantitative reverse-transcriptase polymerase chain reaction, we identified insulin-like growth factor binding protein (IGFBP)-3 as an invasion suppressor gene, which were associated with lower cancer migration, invasion and metastasis. Clinically, lower IGFBP-3 was found associated with significantly higher tumor grade, advanced stage and poor survival in patients with EC tumors. Furthermore, we have proved IGFBP-3 expression correlated with lower Erk activation, but with no effect on the activation of Akt. All these two signal transduction proteins have crucial roles in cancer invasion. Recently, a novel model of ovarian EC formation from endometriosis was reported, and PTEN was found to be a major protein involved. Inactivation of PTEN has been reported in some ovarian EC tumors and methylation was suggested as one of the major epigenetic changes. This tumorigenesis model has lots of similarity to our established invasion model. Therefore, we plan to study the important of PTEN expression in ovarian EC and if inactivation of PTEN and IFGBP-3 is through methylation. Furthermore, by studying the signal transduction pathways using PTEN and IGFBP-3 transfection, we plan to study the mutual interaction between PTEN and IGFBP-3 on the suppression of tumor invasion in ovarian EC.

PTEN and IGFBP-3 Correlation in Ovarian Carcinoma Invasion

Correlation of PTEN and IGFBP-3 in the Invasion of Ovarian Endometrioid Carcinoma

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Oculocerebral Syndrome With Hypopigmentation

Tumor samples will be collected by the pathologist at the reception of the tumor removed during surgery

Tumor samples

Charlotte DOMBLIDES

Matthieu THUMEREL

Immunotherapy have revolutionized the field of oncology, but response rates are low and all patients relapse, due to cellular and soluble immunosuppressive mechanisms. MDSC are one of the most important immunosuppressive cells, that also harbour non immunologic functions, favouring cancer invasion. These non immunologic functions of MDSC in lung cancer will be better characterized. Indeed, cellular mechanisms will be analysed by in vitro studies, assessing the effect of immunosuppressive cells, provided by fresh tumor samples, on phenotype and functions of lung cancer cell lines. The aim of this study is to better characterize immunosuppressive landscape of NSCLC and mechanisms involved in their protumor functions.

In recent years, immune-based therapies have revolutionized the field of oncology by significantly improving survival of cancer patients. Despite sustained responses, only 20% to 40% of cancer patients respond. It has become clear that the immunosuppressive environment induced by tumor through cellular and/or soluble pathways critically contribute to hinder efficient antitumor immunity. The inhibition of these immunosuppressive networks thus represents an essential prerequisite for the improvement of responses to anticancer immunotherapies. Several immune cell populations have been identified as key actors of tumor-induced immunosuppression, among which are myeloid-derived suppressor cells (MDSC) and regulatory T lymphocytes (Treg). However, in non-small cell lung cancers (NSCLC), the prognostic role of these cells, the mechanisms underlying their immunosuppressive functions, their "non-immunological" protumoral functions and their role in dampening the efficacy of immunotherapies in clinical practice are less characterized. The aim of this project is to better characterize the non immunologic functions of MDSC. We propose to assess in vitro the non-immunological pro-tumor functions of MDSC isolated from lung cancer patients

Role of MDSCs and Cancer Stem Cells and Their Cross Talks in NSCLC

Role of Myeloid Derived Suppressive Cells (MDSCs) and Cancer Stem Cells and Their Cross Talks in Non-Small Cell Lung Cancer (NSCLC)

Functional in vitro studies of the effect of MDSC extracted from resected NSCLC prospectively collected on phenotype and function of lung cancer cell lines

University Hospital, Bordeaux

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Yan Zhang, M.D.Ph.D

Sox2 has been studied in several types of human solid tumors. The investigators found that Sox2 had higher expression level in colorectal cancer and metastatic tissues than normal tissues. So the investigators assumed that whether Sox2 plays an important role in the progression and migration of colon cancer.

In our study, we examined Sox2 expression in archived human colon cancer tissues and found that its Sox2 expression correlates with reduced patient survival, increased tumor grade and metastasis probability.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Colchicine for the Palliative Management of Hepatocellular Carcinoma	NCT01935700	Hepatocellular ... Metastasis Invasion	Colchicine	20 Years - 90 Years	Kaohsiung Medical University Chung-Ho Memorial Hospital
IGFBP-3 in Ovarian Cancer Invasion	NCT00154986	Ovarian Carcino...	immunohistochem...	21 Years - 80 Years	National Taiwan University Hospital
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
PTEN and IGFBP-3 Correlation in Ovarian Carcinoma Invasion	NCT00173407	Ovarian Cancer	immunohistochem...	21 Years - 80 Years	National Taiwan University Hospital
Role of MDSCs and Cancer Stem Cells and Their Cross Talks in NSCLC	NCT06024226	Lung Neoplasms Myeloid-Derived... Immunosuppressi...	Tumor samples	18 Years -	University Hospital, Bordeaux
IGFBP-3 in Ovarian Cancer Invasion	NCT00154986	Ovarian Carcino...	immunohistochem...	21 Years - 80 Years	National Taiwan University Hospital
Identification the Expression of Sox2 in Colorectal Cancer Tissues	NCT01589900	Colorectal Canc...		24 Years - 79 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for invasion

Every month we try and update this database with for invasion cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for invasion

Every month we try and update this database with for invasion cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for invasion cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.