Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Adenocarcinoma

Adenoma

Colorectal Neoplasms

Carcinogenesis

Polyps

Barrett Esophagus

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Precancerous Conditions

Esophageal Diseases

Neoplastic Processes

probe-based integrated Raman spectroscopy and scattering measurements of BE and colorectal tissue during GI endoscopy

probe-based integrated Raman spectroscopy and scattering measurements of Barrett's and colorectal tissue during GI endoscopy

SENSITIVE system

Wouter B. Nagengast, MD, PhD

Jouke J.H. Laan, MD

W B Nagengast, MD, PhD, PharmD

The investigators hypothesize that detection of field cancerization in the GI tract could be performed during endoscopy by performing Raman and scattering measurements. Together with the Technical University of Munich (TUM) and the Universidad Carlos III de Madrid (UC3M), the investigators have developed an investigational medical device that integrates probe-based Raman and scattering measurements for endoscopic purposes: the SENSITIVE system. During preclinical ex vivo studies, the investigators have established that measurements of the SENSITIVE system were able to discriminate between non-field cancerized tissue and field cancerized tissue. Considering these results, the investigators aim to assess the safety of in vivo Raman/scattering during endoscopy. Secondly, the investigators to assess the feasibility of this approach measurements to determine field cancerization in the alimentary tract during endoscopy through the SENSITIVE system.

Esophageal adenocarcinoma and colorectal carcinoma are common conditions that are responsible for high mortality rates among the worldwide population. Respectively, patients with Barrett's esophagus and Lynch syndrome are known to be at risk of developing these lethal conditions. Therefore, these patients are subject to regular endoscopic surveillance in order to screen for the presence of these malignancies in order to detect the lesions during their premalignant stages. However, the intervals at which these screening examinations have been stratified have an empirical basis with an arbitrary span of time leading to a lot of unnecessary invasive examinations in the majority of these patients. Preferably, a tailored strategy is applied to patients that have an established risk of developing a cancerous lesion. In order to achieve this approach, detection of field cancerization could play a key role. Before histopathological manifestations of disease develop, subtle changes in cells and tissue occur as elements of field cancerization. If these changes can be observed in vivo in real-time, field cancerization can be diagnosed. Subsequently, patients could be more precisely stratified in a in high- and low-risk cohorts and intervals of surveillance examinations could be adapted. Furthermore, if field cancerization would be identified in real-time during endoscopy, it could be used during therapeutic endoscopies for assessment of (residual) tissue. For the detection of field cancerization, advanced biomedical optical techniques that can visualize nanoscale biomarkers are required. Therefore, the investigators developed an integrated Raman/scattering modality that can perform probe-based measurements of the alimentary mucosa during GI endoscopy. Raman spectroscopy provides information regarding the biomolecular composition of the tissue while measuring the scattering properties provides structural information on a nanoscale.

During our preclinical studies, the investigators investigated the feasibility of Raman and scattering measurements for detecting field cancerization on human tissue (BE and colon) samples and tissue samples from murine models (intestinal model: villin-Cre/APCco/wt mice, and BE model: L2-IL1B/WT mice, healthy control models: WT mice). Human biopsies included BE and colorectal samples of non-suspected tissue from organs without an established dysplastic lesion (group A; without expected field cancerization), and non-suspected tissue from organs with an established dysplastic lesion (group B; expected field cancerization). In addition, samples were obtained from dysplastic lesions in BE patients (Group C).

Non-affected human tissue samples from Group B showed remarkably concentered results along the Raman spectrum, which appeared to show more similarity to the Raman results of the dysplastic lesion-samples rather than the other non-affected tissue samples from Group. A. The samples from group A showed a large variability of data along their Raman spectrum. This variability hampered to establish significant differences in the non-affected tissue samples from organs without expected field cancerization to the ones from the organs with expected field cancerization. Interestingly, increases in the three parameters measured by the scattering (disorder strength, depolarization rate, and roughness frequency) were all discriminative for non-affected tissue samples from BEs with established field cancerization (Group B) from the non-affected samples from BEs without expected field cancerization (Group A). In the rectum, solely the disorder parameter yielded significant differences between non-dysplastic colon tissue vs tissue from colons with established field cancerization.

In the murine models that grew EAC and intestinal cancer, the Raman measurements of dysplastic tissue samples showed different peaks of wavenumbers in the Raman spectrum compared to the normal tissue samples of the WT at different organ level (forestomach, SCJ, stomach, intestine). Moreover, Raman results enabled differentiation of non-affected tissue samples from mice with field cancerization (i.e. containing an established tumor) compared to normal/non-affected tissue samples from WT mice (i.e. not to have field cancerization). In addition, the combination of parameters of the scattering and PWS modalities result in a sensitive detection modality that van be used in an auxiliary fashion to the Raman cancer screening.

Thus, the investigators hypothesize that an integrated approach of Raman spectroscopy and scattering measurements enable the detection of field cancerization of esophageal and colorectal tissue.

Therefore, the investigators aim to assess the safety of probe-based scattering and Raman measurements using the SENSITIVE system of alimentary mucosa during GI endoscopy.

Early Detection of Cancer Onset Based on Sensing Field Cancerization at the Organ Level in the Alimentary Tract Using an Integrated Stimulated Raman/Scattering Modality for Endoscopic Real-time in Vivo Measurements

Safety of endoscopic Raman/scattering measurements according to AEs, SAEs, and SUSARs

Feasibility of the probe-based measurements for the detection of field cancerization

Technical University of Munich

Universidad Carlos III de Madrid

Biomedical Research Foundation of the Academy of Athens

University Medical Center Groningen

Rare Diseases

Recurrence

Esophageal Neoplasms

Neoplasms, Squamous Cell

Disease Attributes

Esophageal Cancer

Pharmaceutical Solutions

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Coagulants

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Lugol's solution

Hemostatics

Balloon type RFA (12J/cm2, 1 application) will be applied for the entire speckled esophageal mucosa at the 3 months after complete ESD.

Oral prednisolone 30mg/day will be prescribed at day 3 after RFA procedure and continue for 28 days to prevent the post-RFA stenosis.

No intervention; surveillance endoscopy alone

HALO360 System (Covidien GI Solutions, Sunnyvale, California, USA), which has been approved by the US Food and Drug Administration (FDA) and is approved for use in Europe (CE mark) and Taiwan (Ministry of Health and Welfare). Because the HALO 360 balloon catheter has been phased out since 2019, a new Barrx™ 360 Express catheter was used thereafter.

Radiofrequency ablation

The participants will receive meticulous endoscopic examination with Lugol chromoendoscopy and Narrow-band imaging

Endoscopy

Before the RFA intervention, the participants will received Lugol staining over the esophagus

Lugol's Solution (1.5%)

Wen-Lun Wang, Ph.D

Ching-Tai Lee, M.D.

Esophageal cancer is a highly lethal disease, and its incidence is still increasing in the world. Recent advances in image-enhanced techniques such as Lugol chromoendoscopy and narrow band imaging, the number of patients with early esophageal squamous cell neoplasias (ESCNs) detected has markedly increased. Endoscopic submucosal dissection (ESD) enables en bloc resection of the neoplasia, and the resected specimen allows for a pathological assessment to evaluate the curability. However, the patients who received complete ESD for early ESCNs frequently developed metachronous recurrence. The cumulative metachronous recurrence rate at 5 years was 50%, and the mean annual incidence of newly diagnosed metachronous tumors was 10%. Among them, those with "speckled" lugol staining pattern over the esophageal background mucosa have the highest risk and should be seen as a precancerous lesion of ESCCs. This issue is gaining attention in the era of endoscopic treatment, but currently there was no appropriate strategy to prevent the tumor recurrence in these high-risk subjects.

Endoscopic radiofrequency ablation (RFA) is a rapidly evolving therapeutic modality, and recent studies have shown its efficacy and safety for eradicating for flat type early ESCNs. To search a best strategy for the prevention of ESCNs, the investigators thus propose a hypothesis that the preemptive RFA for esophageal "speckled" lugol background mucosa may prevent the metachronous neoplastic recurrence after complete endoscopic resection.

RFA to Prevent Metachronous Squamous Neoplasia Recurrence After Complete Endoscopic Submucosal Dissection

Preemptive Radiofrequency Ablation for Esophageal Speckled Lugol Background Mucosa to Prevent Metachronous Neoplastic Recurrence After Complete Endoscopic Submucosal Dissection ~A Randomized Controlled Study

The initial outcome and the data of adverse events will be shared with other researchers, by mail, when they are available.

Metachronous tumor recurrence is defined as a tumor (high-grade dysplasia or squamous cell carcinoma) recurring at a new site after more than 6 months of complete remission status.

including perforation, dysphagia, stenosis, defined as the failure of a standard endoscope (9.8 mm in diameter) to pass through the stenosis, or others resulting in the patients intolerable and discontinued intervention.

National Taiwan University Hospital

E-DA Hospital

Mouth and Tooth Diseases

Periodontal Diseases

Leukoplakia

Mouth Diseases

Stomatognathic Diseases

Pathological Conditions, Anatomical

Antirheumatic Agents

Analgesics

Ketorolac

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Ketorolac Rinse

In Phase II trials, treatment with ketorolac tromethamine oral rinse has been shown to block periodontal disease progression even in the absence of standard clinical intervention such as scaling and root planing which is routinely done to reduce the periodontal pathogen load that is driving the local destructive host inflammatory response. Resolution of periodontal disease has a favorable effect on normalizing the cellular and biochemical indices of inflammation as reflected by histological changes as well as the levels of prostaglandin E2 (PGE2) and interleukin I beta (IL-1beta). In this trial, we will prospectively evaluate if eliminating the inflammatory process (via inhibition of PGE2 biosynthesis) in the oral cavity has a favorable impact on reversing oropharyngeal leukoplakia. To test this hypothesis, up to 57 prospectively identified individuals with objective findings of oropharyngeal leukoplakia will be randomized to receive either a mouth rinse containing ketorolac or placebo. Ketorolac is a 7-fold selective inhibitor of cyclooxygenase-2 (Cox-2), which has been designed for local delivery to maximize the drug exposure to critical oral target tissues while minimizing gastric and systemic exposure to the drug. All responses will be determined at the three month completion of trial using the response criteria developed at MD Anderson Cancer Center. The drug will be given for three months and then all the patients will be followed for one additional month off all oral treatment to observe for late side effects. Based on the analysis of oral exam and photographically documented change in the pretreatment area of leukoplakia, the response of all patients will be determined.

The evaluation of the outcome will include a measurable secondary endpoint consisting of an assessment of histological change as determined by serial punch biopsies of the oral cavity. In addition, a panel of carcinogenesis and inflammatory markers will be serially measured at baseline, at one month follow up or at study conclusion. In the residual tissue, other bioassays will be evaluated to determine their suitability as intermediate endpoint markers. The purpose of this study is a preliminary evaluation of the effectiveness of ketorolac as a potential chemoprevention agent for oropharyngeal cancer. If ketorolac administration in this preliminary Phase IIB trial is associated with reversal of leukoplakia, then a definitive Phase III chemoprevention trial with a cancer reduction endpoint (most likely in a cooperative group-type setting) may be the next validation step.

Randomized, Double Blind, Placebo-Controlled, Phase IIB Trial of Ketorolac Mouth Rinse Evaluating the Effect of Cyclooxygenase Inhibition on Oropharyngeal Leukoplakia: Collaborative Study of the NCI, NIDCD and the NIDCR

National Cancer Institute (NCI)

Skin and Connective Tissue Diseases

Facies

Keratosis, Actinic

Keratosis

Skin Diseases

Fluorouracil

Patients assigned to ingenol mebutate gel received an application a day for three consecutive days in a pre-determined area

Patients assigned to 5% 5-FU received two applications a day for four weeks in a pre-determined area

an application a day for three consecutive days in a pre-determined area

ingenol mebutate

two applications a day for four weeks in a pre-determined area

5% 5-FU

Luis Antonio Torezan, PhD

Background: 5% 5-fluorouracil cream (5-FU) is a well-established treatment for actinic keratosis (AK) and ingenol mebutate gel (IMB) is a new topical field therapy.

Objective: To compare tolerability and safety of IMB with 5-FU for the treatment of facial AKs.

Methods: Open-label, prospective, randomized, controlled clinical trial with 100 patients with AKs within 25-cm2 contiguous field on the face. IMB was applied daily for three consecutive days. 5-FU was applied twice a day for four weeks. Treatment effect was evaluated at baseline and on days 2, 3, 4, 8, 15, 22, 29, 36 and 43, considering ITT populations.

Safety and Tolerability Study of Ingenol Mebutate Compared to 5-FU to Treat Facial Actinic Keratosis

Evaluation of the Tolerability and Safety of 0.015% Ingenol Mebutate Gel Compared to 5% 5-fluorouracil Cream for the Treatment of Facial Actinic Keratosis: a Prospective Randomized Trial

An additional endpoint was to evaluate adverse effects related to the drugs.

Primary endpoint was to compare the total local skin reaction grading scale (LSR) and the area under the curve (AUC) with respect to duration of effects, using a generalized linear model, assuming a logarithmic link function. Age, Fitzpatrick skin type and site of the treatment were considered as covariates. The scale ranged from 0 to 4 (with higher numbers indicating greater severity) for the following six local skin effects: erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration (maximum score of 24).

A secondary endpoint was to evaluate and compare the AUC for each component of the total LSR using generalized linear models. The effect of treatment on the proportion of patients that completed the assigned treatment regimens was compared using generalized estimating equation model and logarithmic link function.

LEO Pharma

University of Sao Paulo

Associate Professor University of Sao Paulo

Dermatologic Agents

Sunscreening Agents

Aminolevulinic Acid

Methyl 5-aminolevulinate

Photosensitizing Agents

Twenty patients with multiple thin AK on the face will be treated with Daylight Photodynamic Therapy with methyl aminolevulinate Skin biopsies before and after treatment will be performed in an AK lesion and in a field cancerization area.

Patients will be treated with Daylight Photodynamic therapy, following these steps:

1. mild curettage of the AK lesions
2. application of a chemical sunscreen SPF 30
3. application of methyl aminolevulinate cream (Metvix R, Galderma Laboratories)
4. exposition to daylight, for 120 minutes
5. cleaning of the face

Methyl Aminolevulinate

Beni Grinblat, md

Luis Torezan, md

Luis torezan, md

Cyro Festa, md

Twenty patients with multiple actinic keratosis on the face will be enrolled in the study and will be treated with Daylight Photodynamic therapy.

Before and after skin biopsies will be performed, for histological and immunohistochemical analysis.

Twenty patients with multiple thin actinic keratosis (AK) on the face will be included in the study. They will be informed of the procedure in detail and sign a consent form.

Digital photographs will be done in a standardized way. Prior to treatment, all patients will undergo 2 skin biopsies under local anesthesia and with a 2 mm punch biopsy. One biopsy will be done over an AK lesion and the other in an area with no apparent AK (field cancerization).

The patients will be treated with Daylight Photodynamic Therapy, following these steps:

1. mild curettage of the AK lesions
2. application of a chemical sunscreen with sun protection factor (SPF) 30
3. application of methyl Aminolevulinate cream (Metvix R, Galderma Laboratories)
4. exposition to daylight, for 120 minutes
5. cleaning of the face

Three months after treatment, two new skin biopsies will be collected, 1cm away from the initial biopsies. On the same date, new photographs will be made following the same standards as pre-treatment photographs.

Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization

Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization - Clinical and Histopathological Analysis

Histopathologic analysis in skin biopsies

immunochemistry analysis in skin biopsies

University of Sao Paulo General Hospital

Principal Investigator

application of ingenol mebutate for 3 consecutive days on an area of face/scalp of 25 cm2

application of criotherapy on actinic keratosis present in an area of face/scalp of 25 cm2 different from the ingenol mebutate area

150 mcg / g per day, to be applied on a predetermined area of 25 cm2 of skin of the face or scalp, for 3 days consecutive

Ingenol mebutate

application with 5 seconds of freezing time of each lesion located in a predetermined skin area of 25 cm2 of the face or scalp

cryotherapy

Giuseppe Argenziano, Prof

The main objective of this study is to compare the effectiveness of ingenol mebutate gel (150 mcg / g per day, to be applied on a predetermined area of 25 cm2 of skin of the face or scalp, for 3 days consecutive) cryotherapy (application with 5 seconds of freezing time of each lesion located in a predetermined skin area of 25 cm2 of the face or scalp) in the treatment of actinic keratosis and their field cancerization.

Study details:

This study is randomized. 50 subjects with at least two actinic keratoses of grade I and II, located in two different districts of 25 cm2 skin of the face or scalp, and who meet all the inclusion criteria will be enrolled in the study by the investigators in the three different centers mentioned above.

The investigators will assess the effect of treatment by confocal microscopy and digital dermoscopy. The investigator will acquire images of selected areas of the face and scalp before and after treatment. Data will be collected and analyzed by the coordinating centre.

Procedure for the study:

Recruitment of subjects; random assignment of treatment (ingenol mebutate gel 150 micrograms/g and cryotherapy) to the two skin areas of 25 cm2 of the subject recruited; evaluation of the two areas with reflectance confocal microscopy and digital dermoscope. The measurements will be carried out at time 0, after 1 month and 6 months. The investigator must fill out a form for each subject at the beginning (day 0), after 1 month and at the end of the study (after 6 months). The subject must complete a questionnaire at the beginning (day 0), after 1 month and at the last follow-up visit (after 6 months).

Measurement parameters: Dermoscopy and confocal microscopy will be used to assess the percentage reduction in actinic keratoses and the damage of the cancerous area in the two selected areas treated with ingenol mebutate gel or cryotherapy, respectively.

Adverse / side events will be collected at each visit by the investigator and will be contained in another form.

This study is designed to compare the efficacy of topical ingenol mebutate (150 mcg/g once daily on a selected facial or scalp target area of 25 cm2, for 3 consecutive days) with cryosurgery (applied for a freeze time of 5 seconds, on each lesion included in an area of 25 cm2 on face or scalp)

This is a national, post-marketing (phase 4), on label, interventional, randomized trial.

Subjects will attend a screening visit where they will be assessed for eligibility.

Two areas of treatment in the same patient have to be identified (e.g. scalp and cheek or two different part of the balding scalp), than these two areas will be randomized in a 2:1 ratio: one will be treated with cryosurgery and the other one with Picato Gel.

The cryosurgery will be performed in the same day during the visit (1 application for a freeze time of 5 seconds, on each lesion included in an area of 25 cm2 on face or scalp) Picato gel 150 mcg will be applied at home by the patient, according to current indication (RCP: 3 consecutive days for a total of three application in an area of 25 cm2) Subjects will be followed for 24 weeks (about 6 months) after the cryosurgery application (Visit 1).

Adverse events and patient compliance will be recorded 7 days after cryosurgery application and 5 days after first Picato gel application (Visit 2). The number of AKs present within the treatment areas will be counted at Visit 1 (Baseline AK count) and at Visits 3 - 4 (AKcount). The data obtained will provide information on the effect of Picato gel versus Cryosurgery on recurrence rate of AKs.

Furthermore, the trial will also provide data on the effect of Picato gel versus Cryosurgery on the appearance rate of new AKs.

The final results for all subjects will be included in a Final Clinical Study Report in the original submission. This includes final results for all primary and secondary endpoints as well as 6-month recurrence and Adverse Event data.

Efficacy of Ingenol Mebutate on Actinic Keratoses and Field Cancerization vs Cryotherapy

A Randomized Study to Evaluate the Efficacy of Ingenol Mebutate on Actinic Keratoses and Field Cancerization Compared to Cryotherapy

The primary efficacy endpoint is the percentage change, at the end of the treatment period, in the number of AK lesions that were originally defined in the selected AK target area at baseline. The percentage change in the number of AK lesions is calculated as the number of lesions present at the end of the treatment period in the target area minus the number of AK lesions present in the target area at baseline visit divided by the number of lesions present in the target area at baseline. This variable will be analysed using a non-parametric analysis (Wilcoxon Rank-sum test).

Change from baseline in RCM score of target area and RCM score of cancerization field at the end of the treatment period. Each of the 13 RCM criteria will be scored 0 (absent), 1 (\<25%), 2 (25%-50%), 3 (50-75%), or 4(\>75%). An overall score will be obtained by averaging the RCM scores at the epidermal, DEJ and dermal level. The same approach will be used for the RCM examination of the cancerization field. The above variables will be compared between the groups using a t-test, 95% confidence interval for the between-group difference will be provided.

The count of AK lesions will be performed by exploration and palpation (numeric count) and the presence will be also confirmed by dermoscopic assessment (numeric count)

cosmetic outcome will be evaluated by Patient's assessment of satisfaction to product at the end of the treatment period (specific questionnaire)

University of Campania "Luigi Vanvitelli"

Professor

Skin Neoplasms

Ultrapulse Carbon Dioxide Laser

Cellutome epidermal harvesting system

Rox Anderson, MD

This project aims to treat field cancerization ( pre-skin cancers) in a manner that will reduce the future pre-skin cancers and non-melanoma skin cancers in patients with significant photodamage.

This is 3 year prospective, randomized, controlled comparison of a single treatment with carbon dioxide laser resurfacing vs. carbon dioxide resurfacing plus autologous epidermal skin graft from a non sun exposed site vs. control.

Thirty subjects will receive treatment with each of the modalities.

The primary measures of efficacy are (a) count of the number of actinic keratosis and non melanoma skin cancers, (b) blinded evaluation of severity from standard digital photographs taken before and after the treatments, and (c) change in histology before and after treatment. Safety measures include (a) pain, (b) scarring, (c) wound healing, (d) and infection

Treatment of Field Cancerization for Reduction in Tumor Burden - A Prospective Study

This is done at every visit over the 3 year period

Massachusetts General Hospital

Harvard Medical School Professor in dermatology, Director of the Wellman Center for Photomedicine; and adjunct Professor of Health Sciences and Technology at MIT

For areas where participants at risk is 0, it is because there were no participants in these categories.

Ultrapulse Laser Alone

Ultrapulse Carbon Dioxide Laser

Cellutome epidermal harvesting system

Ultrapulse Laser Plus Cellutome Harvesting System

Control

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

There was only one patient enrolled in this study

Recruitment was very difficult for this study. Due to long study period, patient retention was also difficult. The study was terminated because of low recruitment. One subject started the study and was lost to follow-up, without completing the study.

Elizabeth Morehouse, Clinical Research Coordinator

Zero participants were analyzed because no patients finished this study. Patient recruitment was very difficult for this study, and therefore the study ended prematurely.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Early Detection of Cancer Onset Based on Sensing Field Cancerization at the Organ Level in the Alimentary Tract Using an Integrated Stimulated Raman/Scattering Modality for Endoscopic Real-time in Vivo Measurements	NCT05247346	Esophageal Aden... Barrett Esophag... Colorectal Aden... Colorectal Poly... Colorectal Neop... Colorectal Aden... Carcinogenesis	SENSITIVE syste...	18 Years -	University Medical Center Groningen
RFA to Prevent Metachronous Squamous Neoplasia Recurrence After Complete Endoscopic Submucosal Dissection	NCT03183115	Esophageal Squa...	Radiofrequency ... Endoscopy Lugol's Solutio...	20 Years - 90 Years	E-DA Hospital
RFA to Prevent Metachronous Squamous Neoplasia Recurrence After Complete Endoscopic Submucosal Dissection	NCT03183115	Esophageal Squa...	Radiofrequency ... Endoscopy Lugol's Solutio...	20 Years - 90 Years	E-DA Hospital
Randomized, Double Blind, Placebo-Controlled, Phase IIB Trial of Ketorolac Mouth Rinse Evaluating the Effect of Cyclooxygenase Inhibition on Oropharyngeal Leukoplakia: Collaborative Study of the NCI, NIDCD and the NIDCR	NCT00001698	Leukoplakia Periodontal Dis...	Ketorolac Rinse	-	National Institutes of Health Clinical Center (CC)
Safety and Tolerability Study of Ingenol Mebutate Compared to 5-FU to Treat Facial Actinic Keratosis	NCT02242747	Actinic Keratos...	ingenol mebutat... 5% 5-FU	18 Years -	University of Sao Paulo
Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization	NCT03013647	Actinic Keratos...	Methyl Aminolev...	-	University of Sao Paulo General Hospital
Efficacy of Ingenol Mebutate on Actinic Keratoses and Field Cancerization vs Cryotherapy	NCT02990221	Actinic Keratos...	Ingenol mebutat... cryotherapy	18 Years -	University of Campania "Luigi Vanvitelli"
Treatment of Field Cancerization for Reduction in Tumor Burden - A Prospective Study	NCT02150863	Extensive Photo... Actinic Keratos... History of Nume...	Ultrapulse Carb... Cellutome epide...	18 Years - 85 Years	Massachusetts General Hospital
Treatment of Field Cancerization for Reduction in Tumor Burden - A Prospective Study	NCT02150863	Extensive Photo... Actinic Keratos... History of Nume...	Ultrapulse Carb... Cellutome epide...	18 Years - 85 Years	Massachusetts General Hospital

Spots Global Cancer Trial Database for field cancerization