Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Symptoms and General Pathology

Wounds and Injuries

Breast Neoplasms

Adjustment Disorders

Genetic Predisposition to Disease

Disease Susceptibility

Breast Diseases

Skin Diseases

Disease Attributes

Trauma and Stressor Related Disorders

Mental Disorders

Psychotic Disorders

Quality of Life

Patients who have risk-reduction mastectomy of any type, per protocol inclusion and exclusion criteria.

Scott L. Spear, M.D.

This is a registry for patients who have a risk-reduction mastectomy ("prophylactic mastectomy") due to being at high risk for developing breast cancer, followed by breast reconstruction. Eligible patients include those who have a breast cancer-related gene, a strong family history of breast cancer, or a personal history of high-risk conditions such as cancer in the other breast or ductal carcinoma in situ (DCIS). Patients are enrolled in the registry before surgery, and are followed for up to ten years afterwards. In addition to studying medical outcomes, we will periodically survey patients for quality-of-life issues and psychological well-being. There is no compensation for being enrolled in this registry. This registry is conducted through the Department of Plastic Surgery at Georgetown University Hospital, and is a sub-registry to the Fisher Familial Cancer Registry at the Lombardi Comprehensive Cancer Center at Georgetown University.

Patient operative specimens, blood samples, and saliva samples.

Registry of Mastectomy for Breast Cancer Risk Reduction

Georgetown University

Chief Plastic Surgery

Immediate reconstruction followed by radiation therapy

Radiation therapy followed by delayed reconstruction

Julio A Clavijo-Alvarez, MD

Michael L Gimbel, MD

This study examines the aesthetic outcomes of breast reconstruction after mastectomy for breast cancer in patients who require post-mastectomy radiation treatment. Patients will undergo autologous tissue breast reconstruction either in immediate fashion, prior to radiation treatment, or in delayed fashion, after radiation treatment. Both approaches are acceptable and are practiced clinically. this will be an observational prospective cohort study.

The investigators hypothesize that immediate autologous reconstruction patients who undergo subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom reconstruction is delayed until after radiation, with the additional benefit of avoiding the psychological side effects of breast amputation.

Neo-adjuvant or adjuvant chemo-radiation remains one of the pillars for breast cancer treatment. (1, 2) Administration of radiation before or after autologous soft tissue reconstruction has being shown to alter the aesthetics of the new breast. (3-7) Currently, the optimal timing for autologous breast reconstruction in patients who need postmastectomy radiotherapy remains in debate between surgeons. (8) Various studies have tried to address this problem. However, most of them have been retrospective studies (3, 7, 9) and the prospective ones have not have enough patients, have mixed population of patients or the radiation protocols have not been normalized. (5, 6, 10)

We hypothesize that immediate autologous reconstruction patients who undergo subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom reconstruction is delayed until after radiation, with the additional benefit of avoiding the psychological side effects of breast amputation.

Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer

University of Pittsburgh

Skin Neoplasms

Nevus, Pigmented

Nevus

Melanoma

Nevi and Melanomas

Neoplasms by Histologic Type

Guillaume CAPTIER, MD.PhD

Depending on its dimensions, it is difficult to predict if a congenital nevi of the lower limb can be surgically removed by a unique simple procedure or by a complex procedure (expander, skin graft etc..), with a good result.

This study retrospectively reviewed the practice of our team of surgeons depending on the size of the naevus to reveal a dimension threshold that can be used in the future to help to choose between a simple or a complex procedure.

Retrospective study using medical file data only. No intervention nor phone call etc.. to the patients or their parents.

Congenital Naevi of Lower Limb in the Child

Congenital Nevi in the Lower Limb in Children : Which Size Can be Afforded by a Simple Surgical Procedure ?

post-operative complications depending on the initial size of the naevus : percentage of complication rate

University Hospital, Montpellier

Head and Neck Neoplasms

Patients randomized to undergo gastric pull up surgical reconstruction of pharyngoesophageal defect.

Patients randomized to undergo free flap (anterolateral thigh or radial forearm) surgical reconstruction of pharyngoesophageal defect.

Using gastric tissue to reconstruct the esophagus and pharynx after pharyngo-esophagectomy.

Gastric Pull Up

Using radial forearm free flap or anterolateral thigh free flap to reconstruct the cervical esophagus and pharynx after pharyngectomy and cervical esophagectomy.

Free Flap Surgery

Prisman Eitan, MD, FRCSC

Oleksandr Butskiy, MD

Eitan Prisman, MD

This study will compare the gastric pull up (GPU) with the free flap \[(specifically, anterolateral thigh (ALT) and radial forearm free flap (RFFF)\] techniques used in the reconstruction of alimentary tracts in patients who require laryngectomy and circumferential pharyngectomy for carcinoma resection. These two interventions will be compared by block randomizing 20 patients based on history of failed chemoradiation to undergo either ALT or RFFF. The primary outcome will be the type and number of postoperative complications. The secondary outcomes will include swallowing function, speech, and quality of life measures along with cancer specific endpoints.

Gastric Pull up Versus Free Flap Reconstruction for Laryngo-pharyngeal Defects

Gastric Pull up Versus Free Flaps Reconstruction (Anterolateral Thigh and Radial Forearm Free Flap) for Laryngo-pharyngeal Defects: A Prospective Randomized Trial

Individual participant data will not be shared with other researchers.

Complications will be divided by: (1) in-hospital mortality (2) reconstruction related complications (anastomotic leak, fistula formation, flap necrosis, flap stenosis or stricture, requirement for surgical revision), and (3) addition in-hospital complications ( bleeding, pulmonary, cardiac, infectious, abdominal, wound concern)

Time from first incision to the end of surgical closure as documented on the nursing record.

Total volume of blood lost and accounted for in suction canisters as documented in nursing charts. (this excludes blood not accounted for in the suction containers)

Requirement for transfusion, measured in units of blood.

Donor site associated quality of life (Toronto Extremity Salvage Score - Upper Extremity)

Donor site associated quality of life (Toronto Extremity Salvage Score - Lower Extremity)

Time from surgery to return of diet that is sufficient for patient to maintain nutrition without requiring G-tube or NG feeding. Patient or Speech Language Pathology reported.

Whether patients are still feeding tube dependent for nutrition at 1 year follow up.

M.D. Anderson Dysphagia Inventory for assessment of dysphagia

Assessed with the dumping symptom rating scale

Measure with combined scores of two questionnaires: European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ) - C30 and EORTC QLQ - H\&N35

Will be classified as positive and negative based on what is reported at Vancouver General Hospital Pathology reports generated at the time of surgery. A measure of clearance in millimeters will also be provided.

time from the date of the surgery until local, regional, or metastatic disease is detected

Time from the date of the surgery until a patient experiences a recurrence, a new primary cancer or death

Time from the date of the surgery until a patient shows sign of disease progression

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Registry of Mastectomy for Breast Cancer Risk Reduction	NCT00555503	Quality of Life Mastectomy Breast Neoplasm... Genetic Predisp... Adjustment Diso...		18 Years - 70 Years	Georgetown University
Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer	NCT00845078	Breast Radiotherapy Aesthetics Treatment Outco... Surgical Recons...		18 Years - 70 Years	University of Pittsburgh
Congenital Naevi of Lower Limb in the Child	NCT04297579	Congenital Mela...		- 18 Years	University Hospital, Montpellier
Registry of Mastectomy for Breast Cancer Risk Reduction	NCT00555503	Quality of Life Mastectomy Breast Neoplasm... Genetic Predisp... Adjustment Diso...		18 Years - 70 Years	Georgetown University
Gastric Pull up Versus Free Flap Reconstruction for Laryngo-pharyngeal Defects	NCT03171558	Head and Neck N... Pharyngectomy Reconstructive ...	Gastric Pull Up Free Flap Surge...	18 Years -	University of British Columbia
Gastric Pull up Versus Free Flap Reconstruction for Laryngo-pharyngeal Defects	NCT03171558	Head and Neck N... Pharyngectomy Reconstructive ...	Gastric Pull Up Free Flap Surge...	18 Years -	University of British Columbia

Spots Global Cancer Trial Database for reconstructive surgical procedures